Anticlotting drug wins FDA panel’s approval

TRENTON, N.J. – Outside advisers to the Food and Drug Administration voted Thursday to recommend that the agency approve a new anticlotting drug for use in millions more patients.

Johnson & Johnson and partner Bayer Healthcare of Germany, which jointly developed the drug, Xarelto, are seeking U.S. approval for preventing strokes in patients with a common irregular heart rhythm known as atrial fibrillation. The drug is already approved to prevent clots in people getting knee and hip replacements.

Nine panel members voted to recommend approving Xarelto to prevent strokes in patients with atrial fibrillation. Two members voted against that and one person abstained. The FDA is expected to make a final decision by early November.

The panel’s vote came despite a very negative review by FDA staff released two days ago. It stated that the latest study of Xarelto didn’t convincingly prove it’s as effective and safe as the longtime standard treatment, warfarin, citing questions about potential stroke and bleeding risks. It also questioned the reliability of some of the data.

The vote came near the end of a daylong hearing that covered technical details of the design of and results from a huge study funded by the companies and meant to show Xarelto works better than warfarin.

Patients and doctors have long wanted a better treatment than inexpensive warfarin because it’s difficult to maintain the correct dose in the blood. Too much warfarin can cause dangerous internal bleeding, and too little can result in strokes.