FDA to Rule on Type 2 Diabetes Drug in Mid-2016

The FDA has accepted a New Drug Application (NDA) for Sanofi’s fixed-ratio combinational drug basal insulin glargine 100 units/mL and GLP-1 receptor agonist lixisenatide for type 2 diabetes in adults.

The application follows data from a pair of phase 3 studies that met their primary endpoints. The study enrolled 1900 patients with diabetes insufficiently controlled after basal insulin therapy and oral antidiabetic agents to test the safety and efficacy of the fixed-ratio combination.

The FDA decision is anticipated for August of 2016.

"The FDA filing notification is an important milestone for Sanofi as we work to broaden our diabetes portfolio," said Executive Vice President of Sanofi, Pascale Witz. "Physicians may need to consider fasting and mealtime blood glucose imbalances in their overall management of diabetes, and additional treatment options are needed. We look forward to working with the FDA during the review process with a view toward bringing this investigational medicine to adults with type 2 diabetes in the US."

Thus far, the regulatory submission is on track for the European Union in March 2016. The fixed-ration combination has not been evaluated for efficacy and safety by regulatory authorities. GLP-1 receptor agonist lixisenatide was studied in type 2 diabetes patients and is under review by the FDA.

The NDA for lixisenatide was accepted in September 2015 and it is anticipated the FDA will make a decision in July 2016.