FDA Panel Recommends Label Change for Lilly’s Jardiance

A U.S. Food and Drug Administration (FDA) panel on Tuesday voted yes, that the diabetes drug Jardiance, manufactured by Eli Lilly and Boehringer Ingelheim, also reduces the risk of cardiovascular death — and that its label should be updated to include this claim.

The panel’s vote was narrow, coming in at 12 to 11. Next, the FDA will decide whether to follow this recommendation.

The FDA approved Jardiance (empagliflozin), an SGLT2 inhibitor, in 2014 to lower blood sugar in patients with type 2 diabetes.

In January, the companies submitted results from an additional clinical trial, which showed Jardiance cut the combined risk of cardiac death, non-fatal heart attacks and non-fatal strokes by 14 percent. The diabetes drug cut the risk of death from any cause by 32 percent. However, there was no significant difference in the risk of non-fatal heart attack or non-fatal stroke.

Prior to the label change recommendation, the FDA asked advisors to determine if “this single trial provides substantial evidence necessary to establish a new benefit.” Normally efficacy claims require additional trials although there are instances “in which a single adequate and well-controlled study has served as the basis for a claim.”

Jardiance revenue was $38.2 million in Q1, up 99 percent, with nearly $30 million coming from the U.S., according to Lilly.

Other SGLT2 inhibitors on the market include Johnson & Johnson’s Invokana and AstraZeneca’s Farxiga.