FDA approves Farxiga for HF patients with reduced ejection fraction

The FDA has approved a new treatment option, Farxiga oral tablets, for adult heart failure patients with reduced ejection fraction. Farxiga, sold by AstraZeneca Pharmaceuticals, was previously approved for the treatment of type 2 diabetes.

“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, said in a statement. “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.”

The FDA highlighted Farxiga’s performance in a recent clinical trial of  more than 4,500 patients. The average participant age was 66 years old and 77% were male.  While some participants were given a daily dose of Farxiga, others were simply given a placebo. After 18 months, taking Farxiga was associated with fewer cardiovascular deaths and hospitalizations for heart failure.

There are, however, key side effects patients should know.

“Farxiga can cause dehydration, serious urinary tract infections and genital yeast infections,” according to the FDA statement. “Elderly patients, patients with kidney problems, those 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. Farxiga can cause serious cases of necrotizing fasciitis of the perineum in people with diabetes and low blood sugar when combined with insulin.”