The US FDA has scheduled an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting for Tuesday, June 28, 2016. The Committee will discuss a supplemental new drug application (sNDA) for empagliflozin (Jardiance) tablets, and for empagliflozin and metformin hydrochloride (Synjardy) tablets. Both sNDAs are sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (BI), for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk, to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure. Both drugs are part of an “alliance in diabetes” between BI and Eli Lilly and Company.
See the SAC Tracker report