FDA Approves Xarelto for Nonvalvular AFib Patients

 

November 9, 2011

Janssen Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has approved Xarelto to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AFib). Xarelto is an oral anticoagulant that offers once-daily dosing without the need for routine blood monitoring.

The drug is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular AFib at a dose of 20 mg once daily; it is also approved at 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 Xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.

Approval was based on the 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. In the trial, once-daily rivaroxaban effectively reduced the risk of stroke and systemic embolism in patients with nonvalvular AFib, 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.

For more information: www.janssenpharmaceuticalsinc.com

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