Jardiance empagliflozin regulatory update

Eli Lilly and Boehringer said FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 12-11 that data from the EMPA-REG OUTCOME cardiovascular outcomes trial of diabetes drug Jardiance empagliflozin showed “substantial efficacy” in reducing CV mortality. The committee also voted 23-0 that the data showed Jardiance does not result in an unacceptable increase in CV risk.

An sNDA seeking to add CV risk reduction based on data from EMPA-REG OUTCOME for Jardiance is under FDA review (see BioCentury, Feb. 1). In EMPA-REG OUTCOME, the group receiving Jardiance had a 38% lower risk of CV death than the placebo group. ...