FDA panel votes in favor of vernakalant approval

BELTSVILLE, Md. An advisory panel for the Food and Drug Administration has voted 6-2 in favor to recommend the approval of a new intravenous—and potentially oral—drug used to treat atrial fibrillation, according to Reuters.

The drug, which is developed by Astellas Pharma and Cardiome Pharma, is being called vernakalant. Atrial fibrillation is when the heart’s upper chambers beat abnormally, putting them at risk for blood clots and strokes.

The drug’s risks include developing a dangerously slow heartbeat, low blood pressure, excessive bleeding, and a rhythm disturbance that can be fatal. Members of the panel expressed concerns over the effectiveness of the drug past 48 hours.

The companies are seeking use of the drug for patients who have had atrial fibrillation for up to a week, but the data does not support a benefit much past two days, panel members said.

“I think it should be clearly stated [on the drug’s label] how low the efficacy is beyond 48 hours,” said Barry Massie, a panel member and chief of cardiology at the San Francisco Veterans’ Administration Hospital.

About 2.2 million Americans suffer from atrial fibrillation in the U.S., according to the American Heart Association. The agency is expected to issue a final ruling on the drug by Jan. 19.