FDA panel narrowly favors CV efficacy claim for Jardiance

On Tuesday, FDA's Endocrinology and Metabolic Drug Advisory Committee voted 12-11 that data from the EMPA-REG OUTCOME cardiovascular outcomes trial (CVOT) show diabetes drug Jardiance empagliflozin show "substantial efficacy" in reducing CV mortality. The committee also voted 23-0 that the data show that Jardiance does not result in an unacceptable increase in CV risk.

Boehringer Ingelheim GmbH (Ingelheim, Germany) and partner Eli Lilly and Co. (NYSE:LLY) are seeking to add an efficacy claim to the label of the sodium-glucose cotransporter 2 ( SGLT2) inhibitor based on EMPA-REG OUTCOME. ...