The FINANCIAL -- Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration  has approved XARELTO to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

XARELTO is the only oral anticoagulant approved in the U.S. that offers once-daily dosing, without the need for routine blood monitoring.XARELTO 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 XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled.

Atrial fibrillation is the most common cardiac rhythm disorder and affects more than 2.2 million people in the U.S. In patients with AFib, the heart’s irregular heartbeat makes them vulnerable to the formation of a blood clot in the atria, which sometimes can break off and travel to the brain, potentially resulting in a stroke. The presence of common conditions such as high blood pressure, heart failure, diabetes, and prior stroke, along with being over the age of 75, are factors that further increase the risk of stroke in people living with AFib. People living with AFib are at a five-fold increased risk for stroke compared with the general population.

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