Large Molecule / Drug Approvals

FDA panel split on Sanofi-Lexicon diabetes drug

Jan 21, 2019

A U.S. FDA advisory panel voted 8-8 over whether to recommend approval of a treatment for type 1 diabetes developed by Sanofi and Lexicon Pharmaceuticals.

Zynquista (sotagliflozin) is a once-daily oral medicine, used as an add-on to insulin therapy. The drug is designed to help manage and maintain glucose levels while reducing the risk of hypoglycemia.

FDA staff flagged the risk of diabetic ketoacidosis (DKA), leaving experts divided over whether the treatment’s benefits outweighed the risks.

“We will continue to work with the FDA through its review process to hopefully bring to patients a new treatment that can help people living with type 1 diabetes control their blood sugar and address some of the challenges of insulin-only therapy,” said Rachele Berria, M.D., PhD, Global Vice President and Head of Diabetes Medical Affairs, Sanofi.

Read the press release