FDA approves Sanofi's lixisenatide

FDA approved Adlyxin lixisenatide from Sanofi (Euronext:SAN: NYSE:SNY) as an adjunct to diet and exercise to treat Type II diabetes. The once-daily glucagon-like peptide-1 receptor ( GLP-1R; GLP1R) agonist is marketed as Lyxumia in over 40 countries, including most EU countries and Japan. Sanofi spokesperson Susan Brooks said the pharma expects to disclose Adlyxin's U.S. price when it decides on a launch date.

Sanofi expects a decision in August from FDA on another Type II diabetes therapy, iGlarLixi lixisenatide/ insulin glargine, a fixed ratio combination of lixisenatide and Sanofi's Lantus insulin glargine. In May, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-2 to recommend approval of iGlarLixi (see BioCentury Extra, May 25). ...