FDA Approves Farxiga For Adults With HF With Reduced Ejection Fraction

Heart of Health Policy | FDA Update: Farxiga

The U.S. Food and Drug Administration (FDA) on May 6 approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. This announcement comes after the FDA approved Farxiga last fall to reduce risk of HF in adults with type 2 diabetes and multiple cardiovascular risk factors or established cardiovascular disease.

In the DAPA-HF trial of 4,744 participants, Farxiga was shown to improve survival and reduce the need for hospitalization in adults with heart failure with reduced ejection fraction. "After about 18 months, people who received Farxiga had fewer cardiovascular deaths, hospitalizations for HF, and urgent heart failure visits than those receiving the placebo," the FDA said.

Farxiga is the first in the sodium-glucose co-transporter 2 (SGLT2) inhibitor drug class to be approved for treating adults with HF with reduced ejection fraction. "This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA's Center for Drug Evaluation and Research.

Read the full FDA announcement, including dosage studied and reported side effects, here.

Keywords: ACC Advocacy, Sodium-Glucose Transporter 2, United States Food and Drug Administration, Heart Failure


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