Janssen Pharmaceuticals announced that the FDA has approved Xarelto (rivaroxaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. This approval was based on data from 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 per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism.
In the primary analysis, the primary end point occurred in 188 patients in the Xarelto group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the Xarelto group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1,475 patients in the Xarelto group (14.9% per year) and in 1,449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the Xarelto group.
Xarelto, a Factor Xa inhibitor, is already indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism in patients undergoing knee and hip replacement surgery.
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