FDA approves empagliflozin for reducing risk of cardiovascular death, hospitalization among adult HFpEF patients
The U.S. Food and Drug Administration (FDA) has approved empagliflozin (Jardiance) as a treatment option for reducing the risk of cardiovascular mortality and hospitalization among adult heart failure patients, regardless of left ventricular ejection fraction.
Empagliflozin is an SGLT2 inhibitor sold by Boehringer Ingelheim and Eli Lilly and Company under the name Jardiance. It was originally designed to helps adult patients with type 2 diabetes (T2D) improve glucose control, an indication the FDA approved back in 2014.
In August 2021, the medication gained FDA approval as a treatment option for adult patients with HF with reduced ejection fraction (HFrEF). In September 2021, it received the FDA’s Breakthrough Therapy designation an investigational treatment for adults with HF with preserved ejection fraction (HFpEF), which is now covered under this new FDA indication.
“While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure,” Norman Stockbridge, MD, PhD, director of the division of cardiology and nephrology in the FDA’s Center for Drug Evaluation and Research (CDER), said in an agency statement. “Coinciding with February’s annual observance of American Heart Month—a reminder for individuals to focus on cardiovascular health—this action will provide physicians another tool to address heart disease.”
The FDA said results from the EMPEROR-Preserved trial helped guide its final decision.
Empagliflozin has been the subject of several academic studies in recent months. A recent study in European Heart Journal, for instance, found that it could provide a wide variety of heart failure patients reduce their risk of hospitalization. Another analysis in JACC: Cardiovascular Imaging highlighted the drug’s ability to reduce extracellular volume among patients with T2D.
Back in 2019, the FDA published a document highlighting its efforts to encourage more heart failure medications to be developed.
“Despite the availability of drugs and devices to treat heart failure, it remains a cause of significant disability, has major effects on physical function and quality of life, and is a leading cause of death,” Ellis Unger, MD, a representative from the CDER, said at the time.
More information about this FDA clearance can be read here.
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.