Results from the phase 3 trials will be presented next month at the American Diabetes Association Scientific Sessions in New Orleans.
An FDA advisory committee has recommended approval for an investigational therapy for type 2 diabetes (T2D) that combines basal insulin glargine with the GLP-1 receptor agonist lixisenatide, according to a statement from the manufacturer, Sanofi.
Approval from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) came with a 12-2 vote, the statement said. The panel recommended approval for a therapy that combines 100 units/mL basal insulin glargine and lixisenatide, a glucagon-like peptide-1 receptor agonist. Of note, the GLP-1 receptor agonist has already been studied for its long-term cardiovascular safety; the ELIXA results were presented in June 2015 in Boston at the 75th Scientific Sessions of the American Diabetes Association (ADA).
“We are pleased by the Advisory Committee's recommendation for approval of this investigational diabetes therapy,” said Elias Zerhouni, president of Global Research and Development for Sanofi. “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 A1C 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. We look forward to continuing to work with the FDA as it completes its reviews of these New Drug Applications.”
The NDA submission was based on data from 2 phase 3 studies that enrolled 1900 adults to evaluate safety and efficacy of the insulin/lixisenatide combination. These results will be presented at the upcoming 76th ADA Scientific Sessions in New Orleans.