Janssen Research & Development announced that the FDA has assigned a Priority Review designation to its supplemental New Drug Application (sNDA) filed for Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).
The submission was based on results from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) trial.
Xarelto is a factor Xa inhibitor, oral anticoagulant. It is currently indicated for the prophylaxis of deep vein thrombosis in people undergoing knee- or hip-replacement surgery and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
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