EMDAC recommends NDA approval for Sanofi’s type 2 diabetes treatment
Posted: 26 May 2016 | | 1 comment
The FDA’s EMDAC has recommended the approval of the NDA for the fixed-ratio combination of insulin glargine and lixisenatide…
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and Sanofi’s lixisenatide for the treatment of adults with type 2 diabetes.
The 15-member panel voted 12 to 2 to approve the fixed-ratio combination of insulin glargine and GLP-1 receptor agonist lixisenatide.
Commenting on the announcement, Elias Zerhouni, President, Global R&D, Sanofi, said: “We are pleased by the Advisory Committee’s recommendation for approval of this investigational diabetes therapy. By combining the complementary therapeutic effects of insulin glargine on fasting plasma glucose and of lixisenatide on postprandial plasma glucose, both of which can contribute to HbA1c lowering, this fixed-ratio product may address some of the unmet needs of adults living with type 2 diabetes who are considering initiating or intensifying insulin.”
NDA submission based on two Phase III studies
The NDA submission for the fixed-ratio combination of insulin glargine and lixisenatide is based on data from two Phase III studies that evaluated the efficacy and safety of the combination when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy. Both studies met their primary endpoints.
The NDA submission for lixisenatide is based on results from the GetGoal clinical programme, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes. The NDA submission for lixisenatide also includes findings from the ELIXA study, a long-term cardiovascular (CV) outcomes study in adults with type 2 diabetes and high CV risk (i.e., patients who have recently experienced a spontaneous acute coronary syndrome event).
Lixisenatide and the fixed-ratio combination of insulin glargine and lixisenatide are undergoing FDA review, with decisions anticipated in July and August 2016, respectively. The fixed-ratio combination of insulin glargine and lixisenatide was also submitted for regulatory review in the European Union in March 2016.
In July of 2015, it was discovered that I had type 2 diabetes. By the end of the month, I was given a prescription for Metformin. I stated the ADA diet and followed it completely for several weeks but was unable to get my blood sugar below 140. With no results to how for my hard work, I panicked and called my doctor. His response? Deal with it. I began to feel that something wasn’t right and do my own research. Then I found Rachel’s blog (google ” CURE DIABETES PRO.GQ ” ) . I read it from cover to cover and I started the diet and by the next morning, my blood sugar was 100. Since then, I have a fasting reading between the mid 70s and 80s. My doctor was so surprised at the results that, the next week, he took me off the Metformin. I lost 30 pounds in the first month and lost more than 6 inches off my waist and I’m able to work out twice a day while still having lots of energy. The truth is we can get off the drugs and help myself by trying natural methods.