FDA approves Jardiance to treat adults living with heart failure with reduced ejection fraction – Boehringer Ingelheim + Eli Lilly

Jardiance (empagliflozin) 10 mg has been approved by the FDA to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company announced .Jardiance is not for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR <30 mL/min/1.73 m2 as it is likely to be ineffective in this setting based upon its mechanism of action. Jardiance can be initiated in adults with HFrEF with an eGFR as low as 20 mL/min/1.73 m2.

This approval for Jardiance is based on results from the EMPEROR-Reduced phase III trial, which investigated the effect of adding Jardiance 10 mg versus placebo to standard of care in a broad range of 3,730 adults with and without type 2 diabetes who had heart failure (functional class II, III or IV) and a left ventricular ejection fraction of 40% or less. In the trial, Jardiance significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25% (5.3% absolute risk reduction, 0.75 HR, 0.65-0.86 95% CI) versus placebo. These results were seen regardless of background heart failure standard of care treatments.

A key secondary endpoint analysis from EMPEROR-Reduced 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% (388 events for Jardiance vs. 553 for placebo, 0.70 HR, 0.58-0.85 95% CI). The safety profile was consistent with the well-established safety profile of Jardiance.