FDA Accepts Sanofi’s Diabetes Drug as NDA
The US Food and Drug Administration (FDA) has accepted Sanofi’s New Drug Application (NDA) for the French drugmaker’s investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
This means that the drug will be given a priority review. A decision is expected for August of this year.
Sanofi based its submission on data from two Phase 3 studies, which enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the combination when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively.
Both studies met their primary endpoints and will be presented at a medical congress in 2016, the company said.
According to Sanofi, the safety and efficacy of the fixed-ratio combination have not been evaluated by any regulatory authority previously, and the proprietary name is under consideration. Preparations are on track for regulatory submission in the EU in March 2016.
The investigational GLP-1 receptor agonist lixisenatide was evaluated in patients with type 2 diabetes and is also currently under review by the FDA. The NDA for lixisenatide was accepted in September 2015, and an FDA decision is expected for July 2016.
