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FDA approves XARELTOR

Monday, November 7, 2011 09:34 AM

The FDA has approved XARELTOR to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. XARELTOR is the only oral anticoagulant approved in the U.S. that offers once-daily dosing, without
the need for routine blood monitoring.

XARELTOR is approved to reduce the risk of stroke and systemic embolism in
patients with nonvalvular atrial fibrillation at a dose of 20 mg once daily, or 15 mg once daily for patients with moderate to severe renal impairment, taken with the evening meal. There are limited data on the relative effectiveness of XARELTOR and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled.

The approval of XARELTOR was based on the pivotal, double-blind phase III 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, in which once-daily rivaroxaban effectively reduced the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with major bleeding rates comparable to warfarin. In bleeding categories of great concern, such as bleeding into a critical organ and fatal bleeding, fewer events were observed with rivaroxaban. In the categories of transfusions and gastrointestinal bleed, more events were observed with rivaroxaban.

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