FDA panel backs Sanofi's iGlarLixi

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-2 to recommend approval of Type II diabetes therapy iGlarLixi from Sanofi (Euronext:SAN: NYSE:SNY), a fixed ratio combination of lixisenatide ( ZP10) and Lantus insulin glargine.

Lixisenatide is a glucagon-like peptide-1 receptor ( GLP-1R; GLP1R) agonist, which Sanofi markets outside the U.S. as Lyxumia. Sanofi has exclusive, worldwide rights to the candidate from Zealand Pharma A/S (CSE:ZEAL). Lantus is a synthetic sustained-release subcutaneous insulin analog. ...