FDA Approves Empagliflozin for Adults with Heart Failure, Reduced Ejection Fraction

In clinical trials, empagliflozin significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25%.

The FDA has approved empagliflozin (Jardiance; Lilly) 10 mg for use in adults living with heart failure with reduced ejection fraction (HFrEF), according to a press release.

Approximately half of all individuals with heart failure die within 5 years of their diagnosis, making this an important new treatment option, according to Lilly. Heart failure accounts for more than 1 million hospitalizations in the United States each year, and HFrEF accounts for more than half of heart failure cases.

“Heart failure is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide. As the prevalence of heart failure continues to rise, the need for new treatment options is critical,” said Javed Butler, MD, chairman of the department of medicine at the University of Mississippi, in the press release. “Empagliflozin is a vital new therapeutic option to reduce the risk of cardiovascular death and hospitalization for adults with heart failure with reduced ejection fraction.”

The approval is based on results from the EMPEROR-Reduced phase 3 trial, which compared the effect of empagliflozin 10 mg with placebo in addition to standard of care among 3730 adults with and without type 2 diabetes, all of whom had heart failure and a left ventricular ejection fraction of 40% or less.

Empagliflozin significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25% compared with placebo, and these results were consistent regardless of background heart failure standard of care treatments, according to the study authors.

The key secondary endpoint findings also demonstrated that empagliflozin helped prevent hospitalizations by significantly reducing the relative risk of first and recurrent hospitalization for heart failure by 30%. The safety profile in the trial was consistent with the well-established safety profile of the drug.

“Around half of all people with heart failure, unfortunately, are expected to die within 5 years of diagnosis,” said Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs, cardio-metabolism and respiratory medicine, at Boehringer Ingelheim Pharmaceuticals, in the press release. “The risk of death increases with each hospitalization for heart failure.”

It is contraindicated in patients on dialysis and is not intended for individuals with type 1 diabetes because it may increase the risk of diabetic ketoacidosis. It is also not for use to improve glycemic control in adults with type 2 diabetes and an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 because it is unlikely to be effective in this setting.

“Today’s approval is significant for the millions of people diagnosed with this form of heart failure, offering additional hope for those who have seen limited new treatment options over the last decade,” said Jeff Emmick, MD, PhD, vice president of product development at Lilly, in the press release.

REFERENCE

US FDA approves Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction. News release. Lilly; August 18, 2021. Accessed August 19, 2021. https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jardiancer-empagliflozin-treat-adults-living