Janssen submits rivaroxaban to FDA for ACS treatment

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Janssen Research & Development, a Johnson & Johnson company, has submitted a supplemental new drug application to the FDA seeking approval for the use of rivaroxaban (Xarelto), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).

The filing is supported by data 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, which was presented in November 2011 at the American Heart Association Scientific Sessions and published simultaneously in the New England Journal of Medicine.

Rivaroxaban is an anticoagulant that works by blocking the blood clotting Factor Xa, thereby reducing the tendency to form clots. In the U.S., Xarelto is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism in people undergoing knee or hip replacement surgery, and for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Rivaroxaban is being developed jointly by Janssen and Bayer HealthCare. Marketing rights in the U.S. for Xarelto are held by Janssen Pharmaceuticals.