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ACS Indication Sought for Rivaroxaban

Issue: March/April 2012

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A supplemental New Drug Application for rivaroxaban, a direct factor Xa inhibitor, has been submitted to the FDA for the approval of the drug for reducing the risk for thrombotic CV events in patients with ACS.

The application is supported by results from the phase 3 ATLAS ACS 2-TIMI 51 trial, which were presented at the American Heart Association Scientific Sessions in November and published simultaneously in The New England Journal of Medicine. In the trial, rivaroxaban (Xarelto, Janssen Pharmaceuticals), in conjunction with standard antiplatelet therapy, reduced the risk of CV death, MI and stroke among patients with ACS.

Currently, rivaroxaban is approved in the United States for reducing the risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation.