Reviewers scrutinize Jardiance's CV efficacy data

FDA is asking an advisory committee to vote on whether data from a cardiovascular outcomes trial (CVOT) show diabetes drug Jardiance empagliflozin does not result in an unacceptable increase in CV risk, and that the data demonstrate "substantial efficacy" in reducing CV mortality. The agency's Endocrinology and Metabolic Drug Advisory Committee is to meet on Tuesday to discuss the addition of data from the EMPA-REG OUTCOME study and an efficacy claim on Jardiance's label.

Last September, Boehringer Ingelheim GmbH (Ingelheim, Germany) and partner Eli Lilly and Co. (NYSE:LLY) said EMPA-REG OUTCOME showed Jardiance plus standard of care was superior to placebo plus SOC in reducing CV risk. The sodium-glucose cotransporter 2 ( SGLT2) inhibitor reduced risk by 14% vs. placebo on the combined primary endpoint of CV death, nonfatal myocardial infarction (MI) and nonfatal stroke (see BioCentury Extra, Sept. 17, 2015). ...