USFDA approves Boehringer-Lilly Jardiance to treat HFrEF
Boehringer Ingelheim and Eli Lilly and Company announced Jardiance (empagliflozin) 10 mg has been approved by the US Food and Drug Administration (FDA) 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, 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.

A statement indicated that 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% 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%.

“In the EMPEROR-Reduced trial, Jardiance protected a broad range of adults with heart failure with reduced ejection fraction by reducing risk of cardiovascular death and hospitalization for heart failure, regardless of their baseline heart failure medications or type 2 diabetes status, when added to standard of care. FDA approval of Jardiance in heart failure with reduced ejection fraction, which follows authorization for use in the EU by the European Commission in June, marks an important milestone in our journey to help transform care for adults with heart failure. We look forward to continuing to investigate the potential benefit of Jardiance across cardio-renal-metabolic conditions," Eid said.

EMPEROR–Reduced was a phase III international, randomized, double–blind trial that enrolled 3,730 adults with and without type 2 diabetes. All participants had heart failure (New York Heart Association [NYHA] functional class II, III or IV) for at least 3 months and a left ventricular ejection fraction of 40% or less at their most recent assessment. At randomization, 75% of patients were NYHA class II, 24% were class III and 0.5% was class IV.

Participants were randomized to once-daily Jardiance 10 mg (n=1,863) or placebo (n=1,867), on top of treatment with guideline-directed heart failure therapy. Median follow-up time was 16 months. The composite primary endpoint was defined as time to the first event of cardiovascular death or hospitalization for heart failure.
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