FDA approves new indication for AstraZeneca’s Farxiga

Patients with a certain type of heart failure will soon have a new treatment available.

The Food and Drug Administration has approved AstraZeneca’s Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization.

Heart failure occurs when the heart does not pump enough blood to support the body's needs, and this type of heart failure happens when the heart's main pumping chamber, the left ventricle, is weakened.

Farxiga 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 heart failure with reduced ejection fraction.

"Heart failure is a serious health condition that contributes to one in eight deaths in the United States and impacts nearly 6.5 million Americans," said Norman Stockbridge, director of the division of Cardiology and Nephrology in the FDA's Center for Drug Evaluation and Research. "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."

Farxiga also is approved to improve glycemic control in adults with Type 2 diabetes in addition to diet and exercise, and to reduce the risk of hospitalization for heart failure among adults with type 2 diabetes and known cardiovascular disease or other risk factors.