Jardiance (empagliflozin) 10 mg has been approved by the US FDA to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure with reduced ejection fraction (HFrEF).
The 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 hospitalisation 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 hospitalisation 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.
The approval was granted to Boehringer Ingelheim and Eli Lilly.