Reuters: Regulatory News: UPDATE 1-J&J drug wins wider approval for leg and lung clots

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UPDATE 1-J&J drug wins wider approval for leg and lung clots Nov 2nd 2012, 21:08 Fri Nov 2, 2012 5:08pm EDT Nov 2 (Reuters) - U.S. regulators on Friday approved expanded use of Johnson & Johnson's Xarelto blood thinner to treat blood clots in the legs and lungs and to reduce the risk of such clots recurring after initial treatment. "Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin 60 years ago," the Food and Drug Administration said in a release. The expanded approval will allow doctors to use Xarelto as an alternative to a widely used injectable treatment called enoxaparin. The pill is already approved to reduce the risk of such leg clots, called deep vein thrombosis, and lung clots, following knee or hip replacement surgery. It is also already approved to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. The FDA said it granted the expanded approval based on safety and effectiveness of Xarelto seen in three clinical trials involving more than 9,000 patients with deep vein thrombosis or lung clots. Clots in blood vessels located deep in the leg can break free and travel to the lungs, where they often cause deadly blockages.

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