FDA Approves Empagliflozin (Jardiance) for Heart Failure with Reduced Ejection Fraction
The sodium-glucose co-transporter 2 (SGLT2) inhibitor, Jardiance® (empagliflozin) 10 mg, has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF).
This approval for Jardiance is based on results from the EMPEROR-Reduced phase III trial. In the trial, Jardiance significantly reduced the relative risk of time to cardiovascular death or hospitalization for heart failure by 25%. These results were seen regardless prior standard of care treatments for heart failure.
A key secondary endpoint from the trial demonstrated that Jardiance helped keep patients out of the hospital by significantly reducing the relative risk of first and recurrent hospitalization for heart failure by 30%.