sNDA Submitted for Xarelto for Acute Coronary Syndrome

Janssen Research and Development announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome. The submission was supported by the 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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