The U.S. Food and Drug Administration (FDA)’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has recommended the approval of Sanofi global healthcare company’s New Drug Application (NDA) for the investigational fixed-ratio combination of basal insulin glargine and GLP-1 receptor agonist ‘lixisenatide’, for the treatment of adult type 2 diabetes.
The panel, composed of 15 members, voted 12-2 with one member absent, to approve the fixed-ratio treatment combination.
“We are pleased by the Advisory Committee’s recommendation for approval of this investigational diabetes therapy,” said Sanofi’s president of Global Research & Development, Elias Zerhouni in a press release. “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.”
Lixisenatide is already approved in more than 60 countries under the proprietary name Lyxumia. Lixisenatide alone, and the fixed-ratio combination treatment, are currently undergoing U.S. FDA review. Decisions are expected by July and August 2016, respectively. The fixed-ratio combination of basal insulin glargine 100 units per ml and GLP-1 receptor agonist lixisenatide, is now being reviewed by the European Union but has not yet been approved for use by any health authority.
In the U.S., the NDA submission for lixisenatide alone is grounded on results from the GetGoal clinical program – which enrolled more than 5,000 adults with type 2 diabetes in 13 clinical trials. The submission includes findings from the Phase 3 ELIXA study, a long-term cardiovascular outcomes study in adults struggling with type 2 diabetes combined with high risk of cardiovascular disease, including patients who had experienced a spontaneous acute coronary syndrome event.
The NDA submission for the combination treatment is based on data from two Phase 3 clinical studies, which enrolled over 1,900 adults worldwide, to evaluate its efficacy and safety when used in patient populations insufficiently controlled with oral antidiabetic agents or basal insulin therapy.
The two studies have met primary endpoints. Results are to be presented in June at the American Diabetes Association 76th Scientific Sessions, in New Orleans, La.