Endocrinologic and Metabolic Drugs Advisory Committee

On Tuesday, June 28, 2016, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) members split their votes, by a vote of 12-Yes to 11-No, with no abstentions, on the proposed additional indication for empagliflozin (Jardiance) tablets and for empagliflozin and metformin hydrochloride (Synjardy) tablets, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (BI), for the treatment of adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of cardiovascular death (mortality). Although the Committee split their votes on the efficacy of empagliflozin for the new indication, they voted unanimously, 23-Yes to 0-No, on the question of safety, voting that use of empagliflozin to improve glycemic control would not result in an unacceptable increase in cardiovascular risk.