On Thursday, January 17, 2019, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed a new drug application (NDA) for Zynquista (sotagliflozin) oral tablet, sponsored by Sanofi-Aventis US, LLC (Sanofi), for the proposed indication of use as adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus. Zynquista is being developed in partnership with Lexicon Pharmaceuticals, Inc. The committee was split on whether to recommend approval, resulting in eight members who voted for approval, and eight members who voted against approval.
Back to All Events
Earlier Event: January 16Bone, Reproductive and Urologic Drugs Advisory Committee