A new anticlotting drug that had been seen as a blockbuster comes under scrutiny by a panel of outside advisers to the Food and Drug Administration Thursday, two days after a negative review by FDA staff. Johnson & Johnson and partner Bayer Healthcare of Germany are seeking U.S. approval of Xarelto for preventing strokes in patients with a common irregular heart rhythm called atrial fibrillation. The FDA approved the drug in July for a much smaller patient pool, patients getting knee and hip replacements, a group at heightened risk of dangerous blood clots. Even that approval followed a delay of roughly two years due to FDA concerns about internal bleeding risk.
