Sanofi announced this week that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has recommended the approval of a New Drug Application from the company.
The first application is for a fixed-ratio combination of a GLP-1 receptor agonist lixisenatide and basal insulin glargine at a 100 units per milliliter in order to treat type-2 diabetes in adults. A second application was also submitted for investigational lixisenatide. FDA decisions are expected to come in July and August of this year.
"We are pleased by the Advisory Committee's recommendation for approval of this investigational diabetes therapy," Sanofi Global R&D President Elias Zerhouni said. "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. We look forward to continuing to work with the FDA as it completes its reviews of these New Drug Applications."
The first application was based on two Phase III studies that consisted of approximately 1,900 global volunteers. The announcement notes that each study met their respective endpoints. The full results will be presented at the American Diabetes Association’s Scientific Sessions to take place in June. The second application for lixisenatide was based on a collection of 13 clinical trials that had approximately 5,000 volunteers.