The Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 12 to 2 to recommend approval of Sanofi’s fixed-ratio combination of basal insulin glargine 100 Units/mL and the glucagon-like peptide (GLP-1) receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
The New Drug Application (NDA) submission for the fixed-ratio combination is supported by data from two Phase 3 studies evaluating the safety and efficacy of the product in more than 1,900 patients who were insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints and the full results will be presented in June 2016 at the American Diabetes Association’s 76th Scientific Sessions.
The FDA expects to make a decision on the fixed-ratio combination of basal insulin glargine 100 Units/mL and lixisenatide sometime in August 2016. Lixisenatide monotherapy is also under FDA review with a decision anticipated in July 2016. The application for lixisenatide was initially submitted to the FDA back in 2012 but was withdrawn so that the company could complete a cardiovascular (CV) outcomes trial before seeking approval. The NDA was resubmitted in 2015 with data from the ELIXA study which reported on CV outcomes in patients with type 2 diabetes and high CV risk.
Although not bound by the Advisory Committee’s recommendation, the FDA takes its advice into consideration when reviewing NDAs. Proprietary names for both compounds in the U.S. are under consideration.
For more information visit FDA.gov.