FDA approves heart failure treatment

The U.S. Food and Drug Administration (FDA) has approved a new treatment for a type of heart failure, according to a news release.

Farxiga (dapagliflozin) oral tablets has been approved as a treatment for adults with heart failure with reduced ejection fraction. The drug reduces the risk of cardiovascular death and hospitalization for heart failure. This is the first sodium-glucose cotransporter 2 inhibitor to be approved to treat adults with this form of heart failure, the release says.

This particular form of heart failure occurs when the heart’s main pumping chamber, the left ventricle, is weakened.

“Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans,” Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, says in the release. “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.”

In a randomized, double-blind, placebo-controlled clinical trial, Farxiga was shown to improve survival and reduce the need for hospitalization in adults with heart failure with reduced ejection fraction. There were nearly 5,000 mostly male participants with an average age of 66 and those treated with 10 milligrams of Farxiga showed fewer cardiovascular deaths, hospitalizations for heart failure, and urgent heart failure visits than those on the placebo after 18 months, according to the release.

The FDA has also approved Farxiga 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, the release says.

Side effects of Farxiga include dehydration, serious urinary tract infections, and genital yeast infections. Elderly patients, patients with kidney problems, patients with low blood pressure, and patients on diuretics should be assessed for their volume status and kidney function, Patients with signs and symptoms of metabolic acidosis or ketoacidosis should also be assessed. The drug can cause cases of necrotizing fasciitis of the perineum in people with diabetes and low blood sugar when combined with insulin, according to the release.