Background Analysis: US FDA Advisory Committee to Review Sanofi’s Insulin Glargine and Lixisenatide Injection (LixiLan) for Type 2 Diabetes – MAY 25, 2016 (EMDAC)
The US FDA has scheduled an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting for Wednesday, May 25, 2016. The Committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc. (Sanofi), proposed for the treatment of adults with type 2 diabetes mellitus.
See the SAC Tracker report