FDA Approves New Oral Treatment Option for HFrEF

The US Food and Drug Administration (FDA) has approved dapagliflozin (Farxiga) oral tablets to reduce the risk of cardiovascular (CV) mortality and hospitalization for heart failure (HF) among adults with heart failure with reduced ejection fraction (HFrEF).

Dapagliflozin is the first sodium-glucose co-transporter 2 inhibitor to be approved to treat adults with New York Heart Association’s functional class II-IV HFrEF.

The drug was approved following a clinical trial that showed dapagliflozin was safe and effective, having improved the survival and reducing the need for hospitalization among adults with HFrEF. 

“[HF] is a serious health condition that contributes to 1 in 8 deaths in the [United States] and impacts nearly 6.5 million Americans,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “This approval provides patients with [HFrEF] an additional treatment option that can improve survival and reduce the need for hospitalization.”

Potential adverse effects from dapagliflozin include dehydration, serious urinary tract infections, and genital yeast infections. Dapagliflozin can also cause serious cases of necrotizing fasciitis of the perineum among people with diabetes and low blood sugar when combined with insulin.

The FDA had previously approved dapagliflozin to improve glycemic control among adults with type 2 diabetes in addition to diet and exercise, as well as to reduce the risk of hospitalization for HF among adults with type 2 diabetes and known cardiovascular disease or other risk factors.

—Colleen Murphy

Reference:

FDA approves new treatment for a type of heart failure. News release. US Food and Drug Administration. May 5, 2020. Accessed May 6, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure