First Patent Filed To Regrow Hair With Human Cells By DNA Hair Regeneration

Medicine

John Satino Research Coordinator, at Hair & Scalp Clinics in Clearwater Fl., confirmed their application of a US Provisional Patent, to extract Growth Factors and Circulating Stem Cells from Human Blood, for Hair Re-growth. This has been combined with Aphanizomenon to mobilize CD34+CD133 Stem Cells. The Process involves injecting hair roots on balding scalps, one at a time. Satino stated they have injected over two hundred individuals to date, with one hundred percent success. The company has posted the technical information along with several before and after photos on the website WWW.DNAhairRegeneration.com.

Naturopathic Doctors Offer Natural Therapies to Treat Cervical Dysplasia and HPV

Medicine

National Cervical Health Awareness Month

For women diagnosed with cervical dysplasia or Human Papillomavirus (HPV), naturopathic doctors offer safe and effective treatments that address the root cause. This is according to the Institute for Natural Medicine (INM), which today released a new FAQ about how naturopathic doctors help prevent and treat cervical dysplasia and HPV, in partnership with the American Association of Naturopathic Physicians (AANP).

 

 

The main risk factor for cervical dysplasia is the presence of HPV. Without treatment, advanced cervical dysplasia can progress to cervical cancer. Approximately 40 percent of American women, and 45 percent of men, currently have some form of HPV, putting them at risk.

Focusing on the whole person, naturopathic doctors take the time to identify and address the genetic, environmental, and behavioral/lifestyle factors that cause cervical dysplasia. Naturopathic doctors treat low- and mid-grade dysplasia with a combination of lifestyle modification, therapeutic diets, nutrient and botanical therapies, and local treatment of the cervix. Specific therapies are individualized to the patient based on their diagnosis, emotional, and physical constitution.

“Surgical procedures are often a prescribed treatment for cervical dysplasia. These treatments have risks and complications, and can lead to longer-term impacts on conception and childbirth,” said Michelle Simon, PhD, ND and Chair of the INM Board of Directors. “Naturopathic medicine opens up options for women. There are many natural therapies that treat dysplasia directly, and help the body’s immune system fight and clear the HPV virus.”

The complete FAQ, “How do naturopathic doctors help prevent and treat cervical dysplasia and HPV?” can be found here.

About the Institute for Natural Medicine
The Institute for Natural Medicine (INM) is a national not-for-profit 501(c)(3) organization that provides public education about naturopathic medicine and increases consumer access to naturopathic doctors. As a close partner to the American Association of Naturopathic Physicians, the INM strives to increase consumer and physician choice in safe, effective healthcare that improves patient outcomes and lowers costs. For more information visit www.naturemed.org or call 855-799-4490.

About the AANP
The American Association of Naturopathic Physicians is the professional association that represents licensed naturopathic physicians. The AANP strives to make naturopathic medicine available to every American, and to increase recognition of naturopathic physicians as the identified authorities on natural medicine. Learn more at www.naturopathic.org.

Neurosurgeon performs unique surgery on man with severe neck deformity

Medicine, Science

Surgery first of its kind in the world

A Kettering Physician Network neurosurgeon performed a surgery that no other surgeon in the world has ever done—and he literally gave the patient from Middletown, Ohio a new look on life.

The patient had a severe neck deformity which caused his head to lean to the point where his ear was touching his shoulder. The man had not been able to look up, work or drive for several years. His head and neck were in constant pain.

“It was embarrassing to walk around staring at the ground and not be able to look people in the eyes,” the patient recalls.

He had sought help from surgeons throughout the country and no one was able to help him. A physician in southwest Ohio heard of Kamal Woods, MD, medical director of Kettering Health Network’s Brain and Spine Center located on the campus of Kettering Medical Center in Kettering, Ohio, and recommended that the patient see him.

The patient says Dr. Woods’ confidence was very comforting. “Dr. Woods said he could help me, he wasn’t sure how at first but it was obvious that he was going to find a way,” the patient explains.

“At first glance, I knew that this was going to be a huge challenge,” explains Dr. Woods. “I had never seen anything quite like it before. I reviewed medical literature and could not find any mention of a similar case. We had to go back to the drawing board. I found inspiration just thinking of what a difference successful surgery would make in this patient’s life. We found a way and prayerfully and successfully executed the plan.”

Dr. Woods decided to perform the surgery in three stages. During the surgery, Dr. Woods intentionally broke the patient’s neck in four places to straighten his spine. The patient’s condition improved immensely following this one-of-a-kind procedure.

“It was like night and day,” the patient exclaims. “After I left the hospital, I saw new buildings, trees—things I hadn’t seen in a long time. I was used to seeing the car dashboard. The whole experience was a gift from God, it was life changing.”

The patient says before the procedure, he couldn’t do things like attend a baseball game, see a movie or eat at a restaurant. “I have a new lease on life,” he says.

Kettering Health Network’s Brain and Spine Center has a team of physicians, surgeons and technicians, each with a unique set of skills, who can diagnose and treat diseases and disorders of the brain and spine—including hard-to-treat cases. The center offers the Dayton region and all southwestern Ohio the most advanced diagnostic, surgical and therapeutic neuroscience care.

Kettering Health Network is a not-for-profit network of eight hospitals, 10 emergency departments, and 120 outpatient facilities serving southwest Ohio. The network’s hospitals are KetteringGrandviewSycamore, Southview, Greene Memorial, Soin, Fort Hamilton, and Kettering Behavioral Medicine. Kettering College, a division of Kettering Medical Center, is a fully accredited college that specializes in health science education. Kettering Health Network is recognized as one of the 2017 Truven Health Analytics 15 Top Health Systems in the United States. For more information, visit www.ketteringhealth.org.

Sustained Benefit in Patients with Relapsed/Refractory Mantle Cell Lymphoma Demonstrated by 3½-Year Follow-Up Data of IMBRUVICA® (ibrutinib)

Medicine

Best outcomes observed in patients treated with IMBRUVICA at first relapse; these patients maintained PFS for a median of nearly three years

Today, Janssen Research & Development, LLC (Janssen) announced results of a pooled analysis of relapsed/refractory (r/r) mantle cell lymphoma (MCL) patients treated with IMBRUVICA® (ibrutinib). The extended follow-up data demonstrated that patients treated with IMBRUVICA earlier (after first relapse) experienced the best clinical outcomes, in terms of both efficacy and tolerability. These data (abstract #151) were presented in an oral presentation at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta.1IMBRUVICA, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8224131-janssen-oncology-online-press-kit/

“Data from this large clinical trial data set with extended follow-up support the early use of ibrutinib in patients with relapsed or refractory mantle cell lymphoma,” said Simon Rule, M.D., Professor in Haematology at Plymouth University Medical School, United Kingdom, and lead investigator and presenter of the pooled analysis.* “Long-term follow-up for ibrutinib demonstrates, that in addition to efficacy, new onset adverse events decrease over time and are generally less common when patients are treated earlier.”

MCL is one of several subtypes of B-cell non-Hodgkin’s lymphoma (NHL) and represents about six percent (about 4,200) of new cases of NHL each year in the U.S. MCL usually begins with lymph node enlargement and can potentially spread to other tissues such as the bone marrow and liver.2 Median overall survival for MCL patients is three to four years.3

“We are proud to have helped so many patients worldwide in their battle against blood cancers such as mantle cell lymphoma with IMBRUVICA,” said Craig Tendler, M.D., Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Janssen Research & Development. “Building on today’s oral presentation, we’re pleased that the early clinical benefit first seen with IMBRUVICA in patients with relapsed/refractory MCL has been maintained with longer follow-up, and enhanced for those patients treated earlier in their disease course.”

Abstract #151: Median 3.5-Year Follow-Up of Ibrutinib Treatment in Patients with Relapsed/Refractory Mantle Cell Lymphoma: A Pooled Analysis
Oral presentation: Saturday, December 9, 201712:00 PM ET

The pooled analysis includes results from Phase 2 and 3 studies (SPARK, PCYC-1104, and RAY; n=370), and additional follow up of 87 patients across these studies who enrolled in the long-term open-label extension study, CAN3001. Eighty-three patients were treated with IMBRUVICA for 3 or more years, and 40 patients were treated with IMBRUVICA for 4 or more years. With 3½ years (41 months) of follow up, the median progression free survival (PFS) overall was 13 months, and 33.6 (range, 19.4-42.1) months in patients with one prior line of therapy. The median PFS in patients achieving complete response (CR) was 46.2 (range, 42.1-not estimable) months and the duration of response in these patients was 55.7 (range, 55.7-NE) months. Patients with favorable baseline disease characteristics were more likely to remain on IMBRUVICA for more than 3 years. Overall, 53% (95% CI, 0.47-0.58), 45% (0.39-0.50), and 37% (0.25-0.49) of patients were alive at 2, 3, and 5 years, respectively, and the median overall survival (OS) was 26.7 months.

Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 79.7% of patients, with the new onset events decreasing after the first year. New onset grade 3/4 TEAEs were generally less common in patients who were treated earlier with ibrutinib. In these studies that permitted enrollment of patients with multiple cardiac risk factors, and among patients experiencing grade 3/4 atrial fibrillation, no patients discontinued treatment and <1% had a dose reduction.

About IMBRUVICA
IMBRUVICA® (ibrutinib) was one of the first therapies to receive U.S. approval after having received the FDA’s Breakthrough Therapy Designation. The BTK protein transmits important signals that tell B cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread.4IMBRUVICA targets and blocks BTK, inhibiting the survival and spread of cancer cells, and impacting signaling associated with other serious conditions. Worldwide, IMBRUVICA was used to treat more than 90,000 patients. For more information, visit www.IMBRUVICA.com.

Additional Information about IMBRUVICA®
INDICATIONS
IMBRUVICA® is indicated to treat adults with5

  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
  • Waldenström’s macroglobulinemia (WM)
  • Mantle cell lymphoma (MCL) patients who have received at least one prior therapy
    • Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Marginal zone lymphoma (MZL) patients who require systemic therapy and have received at least one prior anti-CD20-based therapy
    • Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Chronic Graft-Versus-Host Disease (cGVHD) patients who failed one or more lines of systemic therapy

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®.

The mechanism for the bleeding events is not well understood.

IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding.

Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA®. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.

Monitor and evaluate patients for fever and infections and treat appropriately.

Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 13%) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent IMBRUVICA®. Monitor complete blood counts monthly.

Atrial Fibrillation: Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately, and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines.

Hypertension: Hypertension (range, 6 to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®. Adjust existing anti-hypertensive medications and/or initiate anti-hypertensive treatment as appropriate.

Second Primary Malignancies: Other malignancies (range, 3 to 16%) including non-skin carcinomas (range, 1 to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 2 to 13%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA®therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (62%), neutropenia (61%), diarrhea (43%), anemia (41%), musculoskeletal pain (30%), rash (30%), bruising (30%), nausea (29%), fatigue (29%), hemorrhage (22%), and pyrexia (21%).

The most common Grade 3 or 4 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (39%), thrombocytopenia (16%), and pneumonia (10%).

Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9 % (WM [6%] and MZL [13%]) of patients discontinued due to adverse reactions.

cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%), muscle spasms (29%), stomatitis (29%), nausea (26%), hemorrhage (26%), anemia (24%), and pneumonia (21%).

The most common Grade 3 or 4 adverse reactions (≥5%) reported in patients with cGVHD were fatigue (12%), diarrhea (10%), neutropenia (10%), pneumonia (10%), sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).

Twenty-four percent of patients receiving IMBRUVICA® in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.

DRUG INTERACTIONS

CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

CYP3A Inhibitors: Dose adjustment may be recommended.

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA® in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose.

Please see Full Prescribing Information: https://www.imbruvica.com/prescribing-information.

About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com for more information.

Janssen in Oncology
In oncology, our goal is to fundamentally alter the way cancer is understood, diagnosed and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on hematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualized use of our therapies; as well as safe and effective identification and treatment of early changes in the tumor microenvironment. Please visit www.janssen.com/oncology.

About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal.

*Disclaimer: Dr. Rule served as the lead investigator of this Janssen-sponsored clinical study. Dr. Rule does not have a financial interest in the company.

1 Rule, S et al. Median 3.5-year Follow-up of ibrutinib treatment in patients with relapsed/refractory mantle cell lymphoma: a pooled analysis. Oral Presentation at American Society of Hematology Annual Meeting and Exposition 2017; December 2017Atlanta, GA. Abstract #151.
2 Leukemia & Lymphoma Society. Mantle cell lymphoma facts. https://www.lls.org/sites/default/files/file_assets/mantlecelllymphoma.pdf. Accessed October 2017.
3 Herrmann A, Hoster E, Zwingers T, et al. Improvement of overall survival in advanced stage mantle cell lymphoma. J Clin Oncol. 2009;27:511–8.
4 Genetics Home Reference. Isolated growth hormone deficiency. 
http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency
. Accessed April 2017.
5 Janssen Biotech, Inc., Pharmacyclics LLC. IMBRUVICA U.S. Prescribing Information. August 2017

The Leukemia & Lymphoma Society Achieves New Milestones in Offensive Against Acute Myeloid Leukemia, Deadly Blood Cancer

Health, Medicine

LLS Announces Progress in Groundbreaking Precision Medicine Clinical Trial and Significant Investment in New AML Research

The Leukemia & Lymphoma Society®(LLS) continues its assault against acute myeloid leukemia (AML), a deadly blood cancer that kills more than 10,000 Americans a year. LLS today announced its groundbreaking precision medicine Beat AML® Master Clinical Trial is seeing a rapid increase in patients enrolled as more leading cancer centers and biopharmaceutical companies join the collaboration. More than 150 patients are now enrolled in this innovative trial which aims to find new treatments for a blood cancer that has not seen significant treatment improvements in almost 40 years. Seven cancer centers, including Memorial Sloan Kettering Cancer Center (MSK) and the Knight Cancer Institute at Oregon Health and Science University (OHSU), are now enrolling patients.

The Need is Urgent

Each year, more than 21,000 Americans are diagnosed with AML, a rapidly progressing disease that remains one of the most lethal blood cancers. In fact, blood cancers are the third leading cause of cancer deaths in the United States. Despite advances in treating other blood cancers, the standard of treatment for AML – a combination of toxic chemotherapies – has changed very little over the past four decades. Overall prognosis remains poor, with a five-year survival rate of approximately 26 percent for patients, which decreases with age.

As the world’s largest nonprofit health organization dedicated to blood cancers, LLS is leading the charge against AML to help deliver new treatments that will address this urgent, unmet medical need. The Beat AML Master Clinical Trial is giving patients therapies based on their genetic markers – which is a hallmark of this promising precision medicine approach.

“For too long we’ve treated AML as a one-size-fits-all disease when it is really a much more complex grouping of multiple subtypes of blood cancer, and this trial sets out to change that paradigm,” said Louis J. DeGennaro, Ph.D, LLS’s president and CEO. “Our goal with this innovative trial is to deliver the right drug to the right patient at the right time, and we’re encouraged by the progress we’ve seen in the past year.”

In addition to the Beat AML Master Clinical Trial, as part of its comprehensive attack on AML, LLS has also announced a commitment of more than $8 million in new scientific research to discover novel approaches to treating the disease. Among the new projects is a major $5 million, five-year multidisciplinary effort led by Steven Nimer, M.D., at Sylvester Comprehensive Cancer Center, University of Miami working with other experts at Johns Hopkins University and Memorial Sloan Kettering Cancer Institute to develop therapies targeting the mechanisms that switch genes on and off, and which frequently become abnormal in myelodysplastic syndromes (MDS) and AML.

Another important new project is led by Shannon Oda, Ph.D., working in the laboratory of Philip Greenberg, M.D., at Fred Hutchinson Cancer Research Center in Seattle, who is examining new ways to enhance cutting-edge T-cell immunotherapy for AML.

What’s new in LLS’s efforts against AML

More Centers and Pharmaceutical Companies Participating

The most recent cancer center to join the Beat AML Master Clinical Trial is University of MarylandMarlene and Stewart Greenebaum Comprehensive Cancer Center. Maryland joins some of the most prestigious medical centers across the country including MSK, Ohio State University Comprehensive Cancer Center (OSUCCC), OHSU Knight Cancer Institute, Harold C. Simmons Comprehensive Cancer Center at University of Texas Southwestern; University of Chicago Comprehensive Cancer Center; and University of Colorado Cancer Center. Several more cancer centers are expected to join in early 2018.

Two more pharmaceutical companies, Astellas and Takeda, recently joined Alexion, Boehringer Ingelheim, Celgene, and Gilead Sciences, each investigating targeted therapies to treat AML patients based on their subtype. There are now nine active treatment arms, each focused on a specific subtype of AML. The companies are providing the following investigational drugs:  Alexion: samalizumab/ALXN6000 (anti-CD200); Boehringer Ingelheim: BI 836858 (anti-CD33); Celgene: enasidenib/AG-221/CC-90007 (IDH2 inhibitor); Gilead: entospletinib (SYK inhibitor), Astellas: gilteritinib (FLT3/AXL tyrosine kinase inhibitor); Takeda: evonedistat (NAE inhibitor). Only enasidenib has been FDA approved, but as a treatment for relapsed/refractory patients, while it is being tested in a first-line setting in the Beat AML Master Clinical Trial.  None of the others are approved yet for any indications.

Leading Unprecedented Collaboration

One of the unique aspects of the Beat AML Master Clinical Trial is that it is led by a nonprofit health organization.

As a “patients first” organization, LLS is well-positioned to convene this vast collaboration of stakeholders within the cancer ecosystem, including major cancer centers, pharmaceutical companies and several technology companies helping to manage the trial. The trial protocol employs advanced genomic technology performed by Foundation Medicine to identify the cancer-driving genetic mutations in newly diagnosed patients age 60 and older, in order to match them with an investigational drug best suited to their subtype of AML. For this trial, the process is being completed within seven days, a timeframe that is unprecedented in genomic technology.

The Beat AML Master Clinical Trial is expected to eventually include 500 patients and will continue for at least two years at between 15 and 20 clinical sites.

Finally Seeing Progress

Despite progress in treating other forms of blood cancer, AML had suffered through a 40-year drought in new treatments until earlier this year, when four therapies finally broke through to achieve FDA approval. LLS’s investment assisted each of these somewhere along their development pathway. These include:

  • gemtuzumab ozogamicin (Mylotarg) for treatment of adults with newly diagnosed CD33-positive relapsed/refractory AML
  • midostaurin (Rydapt®) in combination with chemotherapy for a subset of patients with a mutation called FLT3
  • enasidenib (IDHIFA®) for AML patients with the IDH2 mutation
  • CPX-351 (Vyxeos), an innovative reformulation of two standard chemotherapies for patients with secondary AML, a high-risk subtype

“Since our founding almost 70 years ago, we have recognized the urgency of finding new and better treatments for patients diagnosed with AML,” DeGennaro said. “After four decades and millions of dollars invested, we are finally seeing results for AML patients that give us real reason for hope.”

The American Society of Hematology (ASH), the premiere medical society dedicated to hematologic malignancies and other blood disorders, has partnered with LLS to raise awareness about LLS’s Beat AML initiative to its more than 16,000 members.

To learn more about the Beat AML Master Clinical Trial visit www.lls.org/beataml.

Media Contact: Andrea Greif (andrea.greif@lls.org914-821-8958, mobile: 914-772-3027)

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society® (LLS) is the world’s largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949 and headquartered in Rye Brook, NY, LLS has chapters throughout the United Statesand Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.

Atox Bio Closes $30 Million Investment

Health, Medicine, Technology

Funds will support Phase 2 study of Reltecimod for Acute Kidney Injury; Phase 3 study of Reltecimod for Necrotizing Soft Tissue Infections (‘flesh eating bacteria’) ongoing

Atox Bio, a clinical stage biotechnology company developing novel therapies for critically ill patients, today announced that it has raised $30 million. The round was led by Arix Bioscience plc with participation from Adams Street Partners, Asahi Kasei Corporation and additional undisclosed investors. Existing investors SR One, OrbiMed, Lundbeckfonden Ventures, Becker and Integra Holdings also participated in the financing. In conjunction with the financing, Jonathan Tobin, PhD, MBA, Investment Manager at Arix Bioscience, and Terry Gould, Partner & Head of Venture/Growth Investments at Adams Street Partners, will join Atox Bio’s board of directors.

Atox Bio will use the proceeds of the financing to advance the clinical development of Reltecimod, its lead product, into Acute Kidney Injury (AKI), a major unmet clinical need in critically ill patients with severe infections. Atox Bio plans to initiate a Phase 2 clinical study in this indication during 2018. Reltecimod is currently being studied in ACCUTE, a Phase 3 clinical study, in patients with Necrotizing Soft Tissue Infections (NSTI).

“We are excited to welcome such high-quality investors into our strong existing syndicate. The closing of this round, which was oversubscribed, reflects the significant achievements we have made to date in the development of Reltecimod,” said Dan Teleman, Chief Executive Officer of Atox Bio. “Our new investors share Atox Bio’s mission of developing therapies for serious, life threatening, conditions in the critical care setting where no other therapies exist.”

“We are delighted to lead this financing round for Atox Bio,” said Jonathan Tobin. “NSTI and AKI are critical unmet medical needs, and we look forward to supporting Atox Bio in developing potentially ground-breaking, valuable treatments for patients with these life threatening conditions.”

About Reltecimod

Reltecimod (AB103) is a rationally designed peptide that binds to the CD28 co-stimulatory receptor and restores the host’s appropriate immune response to severe infections. By modulating, but not inhibiting, the body’s acute inflammatory response, Reltecimod is designed to help control the cytokine storm that could otherwise quickly lead to morbidity and mortality. Reltecimod received Orphan Drug status from the FDA and EMA as well as Fast Track designation.

About ACCUTE

The phase 3 ACCUTE (AB103 Clinical Composite endpoint StUdy in necrotizing soft Tissue infEctions) study is an ongoing randomized, placebo-controlled study, that plans to enroll 290 patients with NSTI at approximately 60 level 1 trauma sites in the US. Patients receive Reltecimod or placebo, administered as a single dose during or shortly after surgical debridement, in addition to standard of care treatment. The primary end point is a clinical composite that evaluates both the local and systemic components of this disease.

About Acute Kidney Injury

Acute Kidney Injury (AKI) involves inflammatory processes in the kidney which can lead to permanent reduction of kidney function and is also associated with an increased risk of death, extended hospitalization, and increased medical cost. AKI affects annually around 3 million patients in the US, Europe and Japan. There are currently no available therapies to treat AKI and the only treatment options are dialysis and supportive care.

About Necrotizing Soft Tissue Infections (NSTI)

NSTI, commonly referred to as ‘flesh eating bacteria’, represent the most severe types of infections involving the skin, skin structure and soft tissues. NSTIs progress rapidly and often result in significant tissue destruction and systemic disease leading to multiple organ dysfunction, failure and death. Currently, there are no approved treatments for NSTIs – the standard of care includes prompt and repeated surgical debridement, aggressive resuscitation and physiologic support, in addition to antibiotics.

About Atox Bio

Atox Bio is a late stage clinical biotechnology company that develops novel immune modulators for critically ill patients with severe infections. Atox Bio has an ongoing contract No. HHSO100201400013 with the Biomedical Advanced Research and Development Authority (BARDA) supporting the development of Reltecimod in NSTI. The Company was established by Prof. Raymond Kaempfer and Dr. Gila Arad from the Hebrew University of Jerusalem and Yissum. For additional information, visit http://www.atoxbio.com

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

Health, Medicine

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

Ogivri, a biosimilar to the cancer drug Herceptin, is approved for HER2+ breast cancer and metastatic stomach cancers

PR Newswire

SILVER SPRING, Md.Dec. 1, 2017 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.

As with any treatment, health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb, M.D. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

The FDA’s approval of Ogivri is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Herceptin. Ogivri has been approved as a biosimilar, not as an interchangeable product.

Common expected side effects of Ogivri for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, difficulty sleeping (insomnia), cough and rash. Common expected side effects of Ogivri for the treatment of HER2+ metastatic stomach cancer include low levels of certain white blood cells (neutropenia), diarrhea, fatigue, low levels of red blood cells (anemia), inflammation of the mouth (stomatitis), weight loss, upper respiratory tract infections, fever, low levels of blood platelets (thrombocytopenia), swelling of the mucous membranes (mucosal inflammation), common cold (nasopharyngitis) and unusual taste sensation (dysgeusia). Serious expected side effects of Ogivri include worsening of chemotherapy-induced neutropenia.

Like Herceptin, the labeling for Ogivri contains a Boxed Warning to alert health care professionals and patients about increased risks of heart disease (cardiomyopathy), infusions reactions, lung damage (pulmonary toxicity) and harm to a developing fetus (embryo-fetal toxicity). Patients should stop taking Ogivri if cardiomyopathy, life-threatening allergic reactions (anaphylaxis), swelling below the skin (angioedema), inflammation of the lungs (interstitial pneumonitis) or fluid in the lungs (acute respiratory distress syndrome) occur. Patients should be advised of the potential risk to a developing fetus and to use effective contraception.

The FDA granted approval of Ogivri to Mylan GmbH. Herceptin was approved in September 1998 and is manufactured by Genentech, Inc.

For more information:
FDA: Information on Biosimilars
FDA: Biologics Price Competition and Innovation Act of 2009
FDA: Office of Hematology and Oncology Products

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

World advancement in food preservation – Fumoir Grizzly has developed the first licensed bacteriocin used to preserve fish

Medicine

Fumoir Grizzly, with partners Université Laval and Merinov, announced that it has completed development of the M35 bacteriocin and its application process. Named Bac M35, this completely natural bioingredient protects fish from growing Listeria monocytogenes (Listeria). The bacteriocin will be integrated in Grizzly’s production chain over the next several weeks. This major discovery also opens the door to applying Bac M35 in all food processing, thus eliminating the risk of Listeria contamination around the world. Bac M35 is a huge breakthrough in food preservation and is the first bacteriocin licensed by Health Canada for this purpose.

Less salt and fewer chemical additives
The M35 bacteriocin is an alternative to traditional microbiological barriers, mainly chemical additives and salt. This bacterial culture, similar to probiotics, is safe for human health and is sourced from a bioingredient naturally present in marine environments. Bac M35 protects fish for 21 days at 4 °C without affecting taste or nutritional content. Ensuring healthier fresh food, Bac M35 is natural, thermostable (remains effective even in varying temperatures) and is not harmful to the environment.

A universal scope
This discovery and especially its application position Fumoir Grizzly as a world leader in food preservation. Given Bac M35’s unique characteristics, no equivalent is currently known anywhere in the world. Fumoir Grizzly intends to market this bacteriocyte internationally. Patent requests have been submitted in the United States and are in progress for Europe. First targeting markets where fish is abundant, the company will bring Chili, Alaska and Norway into its realm. Fumoir Grizzly is also working on the development and improvement of BAC M35 for use with other foods, including fruits and vegetables, cheeses, beef and deli meats. Commercialization will also license the product to multinationals who have already expressed interest and R & D is expected to lead to other applications in other activity sectors.

Innovation quality and health at the heart of Fumoir Grizzly’s mission
“Given the food quality and safety challenges food processors face, the growing world population, the scarcity of resources and the dangers bacteriological contamination pose to human health, Fumoir Grizzly is extremely proud to present and apply Bac M35. We have always made research and development of products and techniques a priority, to ensure the quality and freshness of our fish. That’s what our reputation is built on,” explained Laura Boivin, president of Fumoir Grizzly. The company devotes 15% of its budget to R&D. Developing Bac M35 cost $600,000. The Saint-Augustin company invested $300,000, while the provincial and federal governments supplied the rest (see data sheet).

By applying Bac M35, Fumoir Grizzly promises fish of uncompromising natural quality, without added chemicals or salt. The bacteriocin’s benefits for consumer health (by naturally protecting the fish, and therefore consumers, from Listeria) and the economic benefits for the industry (in helping prevent costly product recalls and losses) positions Fumoir Grizzly as an international leader in its sector. Let us remember that every year in CanadaListeria infects 178 people, causing an average 150 hospitalizations and 35 deaths, with direct and collateral costs of 240 M$ CAN.

The fruit of 15 years of research
Bac M35 is an active bioingredient based on 15 years of research by a team led by Ismaïl Fliss at Université Laval. Fliss is the METABIOLAC Industrial Research Chair in metabolic activity and the functionality of bioprotective lactic cultures. This chair is namely dedicated to testing the bacteriocin’s effectiveness in other agri-food applications. Bac M35‘s application process was developed by Laboratoire Innodal under the supervision of Laurent Dallaire.

About
Fumoir Grizzly is among the five largest fish smokehouses in Canada and is a leading seller of salmon and smoked salmon in Quebec. With a staff of over 65 people during the peak season and a 16,500-square foot plant in Saint-Augustin-de-Desmaures, the company is continuously modernizing its equipment, increasing its production capacity and developing new products to keep its position as a leader in its field. Tying together past, present and future, Grizzly relies on a leading-edge facility and focuses on R&D while retaining its authenticity and desire to preserve ancestral know-how. All the while making healthy, mouth-watering products, of course!

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FDA Approves SUBLOCADE™ (Buprenorphine Extended-Release), the First and Only Once-Monthly Injectable Buprenorphine Formulation to Treat Moderate to Severe Opioid Use Disorder

Medicine

SUBLOCADE Expected to be Available to U.S. Patients in Q1 2018

This announcement contains inside information.

Indivior PLC (LON: INDV) today announced that the U.S. Food and Drug Administration (FDA) has approved SUBLOCADETM(buprenorphine extended- release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days. SUBLOCADE is intended to be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support1. SUBLOCADE is expected to be available to patients in the U.S. in Q1 2018.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8221151-indivior-sublocade-buprenorphine-fda-approval/

“SUBLOCADE is a scientific innovation that represents a new treatment option to help patients attain more illicit opioid-free weeks during their treatment program,” said Shaun Thaxter, Chief Executive Officer of Indivior. “In the Opioid Blockade Study, SUBLOCADE achieved complete blockade of drug-liking effects for a full month in most patients. SUBLOCADE is the first and only therapy that, at steady state, delivers buprenorphine at a sustained rate of at least 2 ng/mL over a one month period. The urgency for this new treatment has never been greater, as the U.S. opioid crisis has been declared a national public health emergency. SUBLOCADE’s approval is an important step forward for patients, families and communities battling the opioid epidemic.”

SUBLOCADE contains buprenorphine, a partial agonist at the mu-opioid receptor1. Mu-opioid receptors in the brain are known to mediate the subjective effects of opioids, including drug-liking, which is the pleasure associated with opioid use2. SUBLOCADE delivers sustained plasma levels of buprenorphine that translate into high mu-opioid receptor occupancy in the brain, which blocks the drug-liking effects of opioids1.

In the SUBLOCADE clinical trial program, average buprenorphine plasma concentrations of 2-3 ng/mL were associated with mu-opioid receptor occupancy ≥70% and the reduction of illicit opioid use.  SUBLOCADE 300 mg delivers average buprenorphine plasma levels of approximately 2 ng/mL after the first injection. The average concentration of SUBLOCADE at steady-state was 3.21 ng/mL and 6.54 ng/mL for the 100 mg and 300 mg doses, respectively1.

Indivior conducted an Opioid Blockade Study (RB-US-13-0002) which investigated the ability of SUBLOCADE 300 mg to block the subjective effects of illicit opioids, including drug-liking. In the 12-week trial evaluating the blocking effect, SUBLOCADE 300 mg fully blocked the drug-liking effects of hydromorphone1.  Hydromorphone is a potent opioid pain medication3 that is commonly used in human studies to evaluate opioid drug-liking2.

SUBLOCADE was evaluated in a 24-week, Phase 3 pivotal study (RB-US-13-0001) in which patients were randomized to one of the following three regimens: six once-monthly SUBLOCADE 300 mg doses; two once-monthly SUBLOCADE 300 mg doses followed by four once-monthly 100 mg doses; or six once-monthly injections of placebo. Both dosage regimens of SUBLOCADE were shown to be superior to placebo in achieving more illicit opioid-free weeks (p<0.0001)1,4. In the clinical trials, the overall safety profile for SUBLOCADE, given by a healthcare provider, was consistent with the known safety profile of transmucosal buprenorphine, except for injection site reactions. The most common adverse reactions (≥5% patients), included constipation, nausea, vomiting, abnormal liver enzymes, headache, sedation and somnolence. Injection site reactions were reported in 16.5% of the patients.  None of the injection site reactions were serious, and only one led to study treatment discontinuation1.

“Every patient’s journey to recovery is different and they face many challenges. To help support these differences, doctors and patients need options for medication-assisted treatment,” said Dr. Brent Boyett, SUBLOCADE clinical investigator and director at Boyett Health Services, Inc. “In a Phase 3 clinical study, SUBLOCADE helped patients refrain from illicit opioids for more weeks compared to placebo. Used in combination with counseling and psychosocial support, SUBLOCADE is a transformational new drug that offers a treatment option for people with moderate to severe opioid use disorder.”

The opioid addiction epidemic in the U.S. is a national public health emergency, with nearly 12 million people impacted nationwide and an average of four people dying from opioid overdose every hour of every day5,6,7. OUD, commonly referred to as opioid addiction8, is a chronic disease that changes the brain9. The patient journey to treatment and recovery is complex, with many barriers such as social stigma, access to treatment and prescribers, and difficulty adhering to treatment plans. Out of the more than 2.5 million patients diagnosed with OUD in the U.S., less than half are treated with medication-assisted treatment (MAT)10.

The economic impact of the opioid epidemic to the healthcare system is significant. The amount paid for treatment of substance use disorders is only a small portion of the costs these disorders impose on society. Data published in 2016 presented the total costs of prescription opioid use disorder and overdose in the U.S. at $78 billion in 2013. Of that, only 3.6 percent, or about $2.8 billion, was for treatment11.  A separate, recent analysis by the White House Council of Economic Advisers estimated the total annual cost of prescription opioid overdose, abuse and dependence in the U.S. at $504 billion in the year 201512. Patients, physicians, policymakers and other stakeholders have expressed the need for additional treatment options in the fight against the chronic relapsing disease of opioid addiction. Indivior has an ongoing, prospective, observational study (RECOVERTM) to understand the clinical, environmental and socioeconomic characteristics of OUD patients13.

“The American Society of Addiction Medicine supports the development and manufacturing of medications that aid in the treatment of addiction,” said Dr. Kelly Clark, President, American Society of Addiction Medicine. “The introduction of novel pharmacotherapies supports this goal. Addiction patients, like all patients, should have available to them a robust and varied array of treatment options, as no one treatment modality is appropriate or therapeutic for everyone.”

“We applaud the scientists and leaders who have been working tirelessly on the development of new, longer-acting medicines for the treatment of opioid use disorder. These exciting new developments will help our patients and families live healthy lives and accelerate the progress in the treatment of addiction,” commented Jessica Hulsey Nickel, President and CEO of the Addiction Policy Forum.

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of SUBLOCADE in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription1.

SUBLOCADE will be distributed through a restricted distribution system, which is intended to prevent the direct distribution to a patient. This is because of risk of serious harm or death that could result from intravenous self-administration.

Indivior worked closely with the FDA to include appropriate warnings and precautions, including a BOXED WARNING in the label and implementation of a Risk Evaluation and Mitigation Strategy (REMS) program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in the SUBLOCADE REMS Program. In addition, Indivior continues to enhance its compliance program to keep pace with the anticipated increase in the number of patients in treatment.

Switching to Toujeo® in a real-world setting produced a similar number of severe low blood sugar events as insulin degludec

Health, Medicine

Two large real-world analyses compared adults with type 2 diabetes who were switched to Toujeo (insulin glargine injection 300 Units/mL) to those switched to insulin degludec

PR Newswire

LOS ANGELESNov. 30, 2017 /PRNewswire/ — Adults with type 2 diabetes who switched their basal insulin therapy to Toujeo® or insulin degludec, experienced similar numbers of low blood sugar (hypoglycemia) events, according to the findings of two comparative real-world studies. Patients also experienced similar reduction of average blood sugar (HbA1c) with the different insulin treatments.

The results were presented today at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S.1,2

The two studies, known as LIGHTNING and DELIVER D, are part of the comparative study program for Toujeo versus insulin degludec. Both studies were retrospective observational analyses based on two different large U.S. databases of electronic medical records and claims using a statistical technique (propensity score matching) for making the treatment groups comparable. This minimizes observed sources of bias typically found in simple observational studies.

“With the patient matching approach used in the two studies, physicians and payers will have access to additional findings to evaluate Toujeo in a real-life setting,” said Riccardo Perfetti, Head of Global Diabetes Medical Team, ‎Sanofi. “Data evaluating the risk of severe low blood sugar (hypoglycemia) can also help educate providers on treatment options.”

LIGHTNING: The largest real-world comparative study in diabetes

The LIGHTNING retrospective observational study1 is the largest real-world comparative study in diabetes. It used statistical techniques, such as propensity score matching and predictive modeling, to evaluate electronic medical records for 130,155 adult patients who were treated with long-acting insulin treatment in the U.S. Optum-Humedica database.

After Propensity Score Matching (PSM), 8,456 adult patients with type 2 diabetes who switched from using insulin glargine 100 Units/mL to Toujeo or insulin degludec were compared in a routine care setting. The majority of patient baseline characteristics were similar across basal insulin treatment groups. Analysis showed that the risk of severe hypoglycemia related to an inpatient or emergency department visit was comparable in both groups of patients (p=0.37) with no differences in HbA1c.

DELIVER D: Further results from the DELIVER comparative program

In the DELIVER D retrospective observational study2, it used electronic medical records (EMR) for 22,492 adult patients who were treated with long-acting insulin treatment in the U.S. Predictive Health Intelligence Environment (PHIE) database. After PSM, 1,620 adult patients with type 2 diabetes who switched from using insulin glargine 100 Units/mL to Toujeo or insulin degludec were compared in a routine care setting. The majority of patient baseline characteristics were similar across basal insulin treatment groups.

During the 6-month follow-up period, patients in both groups showed comparable numbers of patients experiencing any low blood sugar (hypoglycemia) events (p=0.45). The number of patients experiencing low blood sugar events associated with hospital or emergency department visit was also similar in both groups (p=0.80). Reduction in average blood sugar levels (HbA1c) were comparable between the two groups (p=0.97). Patients on Toujeo and those on insulin degludec were equally likely to attain HbA1c < 7.0% (12.9% vs 15.9%, respectively; P = 0.24) and HbA1c < 8.0% (44.2% vs 44.6%, respectively; P = 0.92) during 3-6 months’ follow-up.

While the findings from both studies represent actual patterns of treatment and outcomes outside the confines of clinical trials, electronic medical records are not completed for research purposes and vary in completeness. As a result limitations of these analyses include potential incomplete dosage information, under-reporting of hypoglycemia, and lack of information about reasons for switching treatment. In addition, the PSM process results in a smaller overall dataset compared with the available patient data pool.

What is Toujeo® (insulin glargine injection) 300 Units/mL?

Prescription Toujeo® is a long-acting insulin used to control blood sugar in adults with diabetes mellitus.

  • Toujeo® contains 3 times as much insulin in 1 mL as standard insulin (100 Units/mL)
  • Toujeo® is not for use to treat diabetic ketoacidosis
  • Toujeo® should not be used in children

Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL

Do not take Toujeo® if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo®.

Do NOT reuse needles or share insulin pens even if the needle has been changed.

Before starting Toujeo®, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant or if you are breastfeeding or planning to breastfeed.

Heart failure can occur if you are taking insulin together with pills called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Toujeo®. Your treatment with TZDs and Toujeo® may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms including:

  • Shortness of breath
  • Sudden weight gain
  • Swelling of your ankles or feet

Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, and herbal supplements.

Toujeo should be taken at the same time once a day. Test your blood sugar levels daily while using any insulin, including Toujeo®. Do not change your dose or type of insulin without talking to your doctor. Verify you have the correct insulin before each injection. Do NOT use a syringe to remove Toujeo® from your SoloStar® pen. Your dose for Toujeo® may be different from other insulins you have taken. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix Toujeo® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use Toujeo® only if the solution is clear and colorless with no particles visible.

While using Toujeo®, do not drive or operate heavy machinery until you know how Toujeo® affects you. Don’t drink alcohol or use other medicines that contain alcohol.

The most common side effect of any insulin, including Toujeo®, is low blood sugar (hypoglycemia), which may be serious and can be life-threatening. Severe hypoglycemia may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.

Toujeo® may cause severe allergic reactions that can lead to death. Get medical help right away if you have:

  • A rash over your whole body
  • Shortness of breath
  • Swelling of your face, tongue, or throat
  • Extreme drowsiness, dizziness, or confusion
  • Trouble breathing
  • Fast heartbeat
  • Sweating

Toujeo® may have additional side effects including swelling, weight gain, low potassium, and injection site reactions which may include change in fat tissue, skin thickening, redness, swelling, and itching.

Toujeo® SoloStar® is a disposable prefilled insulin pen. Talk to your doctor about proper injection technique and follow instructions in the Instruction Leaflet that comes with the pen.

Please see full Prescribing Information for Toujeo® on Toujeo.com or click here: http://products.sanofi.us/Toujeo/Toujeo.pdf.

References

  1. Zhou LF et al, “Hypoglycemia risk associated with basal insulin use in type 2 diabetes (T2DM): The Lightning study”, World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S., November 30 – December 2.
  2. Blonde L et al, “Real-world evidence demonstrates comparable clinical outcomes of switching from insulin glargine 100 U/mL (Gla-100) to insulin glargine 300 U/mL (Gla-300) vs insulin degludec (IDeg) in patients with type 2 diabetes (T2D)”, World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S., November 30 – December 2.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.