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news.Janssen Research & Development has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban).
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Xarelto is an oral anticoagulant that reduces the risk of (thrombotic) cardiovascular events in patients with Acute Coronary Syndrome (ACS).
The drug candidate is also being assessed for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role.
The submission of the sNDA is backed by the data from 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.
The US marketing rights for Xarelto are held by Janssen Pharmaceuticals.