FDA advisory committee recommends approval of BI's atrial fibrillation drug

RIDGEFIELD, Conn. A Food and Drug Administration advisory committee has recommended approval of a drug for patients with atrial fibrillation.

The FDA cardiovascular and renal drugs advisory committee voted unanimously to recommend approval for Boehringer Ingelheim's Pradaxa (dabigatran etexilate), for preventing strokes in atrial fibrillation patients. For the last 50 years, warfarin has been the only oral anticoagulant drug available for this purpose.

An estimated 2.3 million Americans have atrial fibrillation, and the prevalence is expected to increase to 5.6 million by 2050, according to a 2001 study published in the Journal of the American Medical Association.

An FDA advisory committee recommendation doesn’t guarantee approval for a drug, but is taken into account when the agency decides whether or not to grant approval.