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news.The US Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) drug by Janssen Pharmaceuticals, used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
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Xarelto, an once-daily oral dosing anticoagulant, works by blocking the Xa blood clotting factor.
The approval of Xarelto is backed by the pivotal double-blind Phase 3 ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation) global clinical trial.
The trial demonstrated that a once-daily rivaroxaban reduced the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with major bleeding rates comparable to warfarin.