FDA Looking to Approve Lixisenatide Type 2 Diabetes Drug

The FDA is considering approval for Sanofi's lixisenatide type 2 diabetes treatment.

The FDA is considering approval for Sanofi’s lixisenatide type 2 diabetes treatment.

Lixisenatide is a once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist. The brand name in the United States is still under consideration, but it approved as Lyxumia in Europe and other countries.

Sanofi originally submitted a New Drug Application (NDA) for lixisenatide in 2013, but the company pulled that application because the FDA was concerned about the cardiovascular safety of similar diabetes drugs.

Now, the FDA has accepted what is the first NDA for a GLP-1 receptor agonist to include cardiovascular outcomes data, Sanofi claims.

These data are based on the results from the phase 3 GetGoal clinical program and the recently completed ELIXA study.

The GetGoal program included more than 5000 patients worldwide and evaluated the safety and efficacy of lixisenatide, while ELIXA compared the cardiovascular safety of the drug to the standard of care in more than 6000 adults with type 2 diabetes and high cardiovascular event risk.

The most common side effects seen with lixisenatide in clinical studies are nausea, vomiting, diarrhea, and headache.