"In its phase III trials, empagliflozin has shown a statistically significant and clinically meaningful benefit in patients with heart failure across the spectrum of ejection fraction," said Javed Butler, M.D., chairman, Department of Medicine, University of Mississippi. "The approval means these demonstrated benefits can now help to address a significant unmet need for the approximately 3 million adults in the U.S. with preserved ejection fraction, a form of heart failure that has very limited treatment options."
Affecting more than 6 million people in the U.S., heart failure is a leading cause of hospitalization and is becoming increasingly prevalent due to the aging population. Just six months ago, Jardiance was approved to reduce the risk of cardiovascular death plus hospitalization for one type of heart failure – heart failure with reduced left ventricular ejection fraction (LVEF). The decision expands this indication to adults with heart failure. As a result, the indication now includes adults with preserved LVEF.
Jardiance is contraindicated in people with hypersensitivity to empagliflozin or any of the excipients in Jardiance, as reactions such as angioedema have occurred, and in patients on dialysis.
This approval is based on results from the landmark EMPEROR-Preserved phase III trial, which investigated the effect of Jardiance 10 mg compared with placebo once daily, both on top of standard of care therapy, in 5,988 adults with heart failure with LVEF over 40%. In the trial, Jardiance demonstrated a 21% relative risk reduction (3.3% absolute risk reduction, 0.79 HR, 0.69-0.90 95% CI) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure. In both EMPEROR-Preserved and EMPEROR-Reduced, the benefit was generally consistent across LVEF subgroups.
A key secondary endpoint analysis from EMPEROR-Preserved showed that Jardiance reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% (407/2997 events for Jardiance vs. 541/2991 for placebo, 0.73 HR, 0.61-0.88 95% CI).
"The EMPEROR-Preserved trial demonstrated breakthrough benefits for a widely underserved group of people who have heart failure. With this news, Jardiance becomes the first and only heart failure treatment to show a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure in adults with heart failure, regardless of ejection fraction," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "This approval, with a decision for use in the EU by the European Commission expected to follow, represents an important milestone in our efforts to redefine heart failure care and advance treatment options for people with a range of cardio-renal-metabolic conditions."
"This approval reinforces the potential of Jardiance as a crucial treatment option to help fill an urgent need for adults across the full spectrum of heart failure," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. "Building on the indication for heart failure with reduced ejection fraction last year, this decision marks the third U.S. FDA approval for Jardiance stemming from the EMPOWER program and adds to a growing legacy of leadership for the Boehringer Ingelheim and Lilly Alliance spanning cardiovascular disease and type 2 diabetes."
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