Heart failure with reduced ejection fraction (HFrEF) can now be treated with the SGLT2 inhibitor dapagliflozin (Farxiga), the .
"This approval provides patients with HFrEF an additional treatment option that can improve survival and reduce the need for hospitalization," Norman Stockbridge, MD, PhD, of the FDA's Center for Drug Evaluation and Research, said in a press release.
Dapagliflozin is already approved for glycemic control in type 2 diabetes, and to reduce the risk of heart failure hospitalization in people with type 2 diabetes and known cardiovascular disease or other risk factors.
The drug's new indication is based on findings from the double-blind, placebo-controlled DAPA-HF trial, in which dapagliflozin was associated with 26% fewer cardiovascular deaths or cases of worsening heart failure in HFrEF patients at 18 months. The heart benefit of the drug was confirmed even for people without diabetes.
How exactly the SGLT2 inhibitor works in heart failure is not well characterized, however.
FDA cautioned that dapagliflozin may cause dehydration, serious urinary tract infections, and genital yeast infections, among other side effects.
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