FDA to Review Eli Lilly’s Jardiance for Heart Failure

The FDA has accepted Eli Lilly’s supplemental new drug application for its diabetes drug Jardiance (empagliflozin) for reducing risk of death or hospitalization and kidney function decline for diabetic and nondiabetic adults with chronic heart failure.

The agency agreed to review the drug after seeing phase 3 results that associated Jardiance with a 25 percent relative risk reduction in the time leading to cardiovascular death or hospitalization due to heart failure.

The drug was first approved in 2014 for lowering blood sugar in adults with type 2 diabetes and for reducing the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.