Strong mortality data lifted Boehringer Ingelheim GMBH and Eli Lilly & Co. to a positive FDA advisory committee review of a cardiovascular benefit claim for Jardiance (empagliflozin), but the panel's closely split vote likely means the question is far from settled for FDA.
Jardiance Mortality Claim Narrowly Endorsed By FDA Advisory Committee
The 12-11 vote supporting new indication for reduced incidence of cardiovascular death provides cover for FDA if it decides more data are needed before granting first CV benefit claim to a diabetes drug.