FDA advisory committee backs approval of Sanofi treatment for adults with type 2 diabetes

The 15-member panel of the Endocrinologic and Metabolic Drugs Advisory Committee voted 12 to 2 (1 panelist did not vote due to travel) to approve the combination.

Two Phase 3 studies, which enrolled over 1,900 adults globally, to assess the efficacy and safety of the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide when used in patient populations insufficiently controlled after oral antidiabetic agents and after basal insulin therapy, met their primary endpoints.

The NDA submission for lixisenatide was based on results from the GetGoal clinical program, which included 13 clinical trials including over 5,000 adults with type 2 diabetes.

It also includes findings from the Elixa study, a long-term cardiovascular outcomes trial in adults with type 2 diabetes and high CV risk.

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 FDA is expected to take a decision on lixisenatide and the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide in July and August 2016, respectively.

Lixisenatide is currently approved in over 60 countries globally under the name Lyxumia.

The fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide was submitted for regulatory review in the European Union in March this year.