June 28, 2016
An FDA advisory panel on Tuesday voted 12 to 11 in favor of an expanded indication for the SGLT2 inhibitor Jardiance, supporting language in the prescribing information that the drug can reduce the incidence of cardiovascular death in patients with type 2 diabetes and a history of cardiovascular disease.
The decision follows an in-depth analysis of primary and secondary endpoints in the EMPA-REG Outcome trial, a randomized, double blind, placebo-controlled study that revealed a surprise CV benefit in patients with type 2 diabetes at high CV risk. The FDA requires that all diabetes drugs undergo testing for CV outcomes. Jardiance (empagliflozin, Boehringer Ingelheim/Lilly) was the first to demonstrate a CV benefit.