Endocrinologic and Metabolic Drugs Advisory Committee

On Wednesday, May 25, 2016 the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) supported, by a vote of 12-Yes to 2-No, with no abstentions, the safety and efficacy of iGlarLixi (insulin glargine and lixisenatide) injection and lixisenatide injection solo product by Sanofi Aventis c/o Sanofi U.S. Services Inc. (Sanofi), proposed for the indication of adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both insulin glargine and Lixisentatide is appropriate. iGlarLixi is a fixed-dose combination of investigational product Lyxumia (lixisenatide), a glucagon-like peptide-1 (GLP-1) receptor agonist, and Lantus (insulin glargine), a long-acting insulin analog. The new drug application (NDA) for Lyxumia (lixisenatide) was also discussed at the meeting.