FDA grants rivaroxaban priority review for ACS patients

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The FDA has assigned a priority review designation to the supplemental New Drug Application (sNDA) filed on Dec. 29, 2011 for rivaroxaban (Xarelto, Janssen Research & Development), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).

The FDA grants priority review to medicines that offer advances in care or that provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA will complete its review within six months from the receipt of the sNDA submission, rather than the standard 10-month review cycle.

The submission was based on results from 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 ACS) trial that were presented in November 2011 at the American Heart Association scientific sessions and published in the New England Journal of Medicine.

Rivaroxaban is an anticoagulant, and works by blocking the blood clotting Factor Xa. In the U.S., rivaroxaban is indicated to reduce the risk of forming a blood clot in the legs and lungs of people who have had knee or hip replacement surgery and to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem.

Limited information is available on how rivaroxaban compares with warfarin in reducing the risk of stroke when the blood levels of warfarin are well-controlled. In addition, rivaroxaban is being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role.

Rivaroxaban is being developed jointly by Janssen and Bayer HealthCare. U.S. marketing rights for rivaroxaban are held by Janssen Pharmaceuticals, which is a Johnson & Johnson company.