FDA Application Submitted for Rivaroxaban to Reduce Secondary Cardiovascular Events


January 9, 2012

January 9, 2012 – Janssen Research and Development, LLC (JRD) announced today that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of Xarelto (rivaroxaban), 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 or without thienopyridine therapy in Subjects with acute coronary syndrome) trial, which was presented in November at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine.

ACS is a complication of coronary heart disease, the leading cause of death in the United States. and also one of the most prevalent non-communicable diseases in the world. ACS occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart. This disruption of blood flow can cause a heart attack or unstable angina, a condition signifying that a heart attack may soon occur. Each year, an estimated 1.2 million patients in the United States are discharged from the hospital with a primary or secondary diagnosis of ACS.

Xarelto belongs to a group of medicines called anticoagulants, and works by blocking the blood clotting Factor Xa, thereby reducing the tendency to form clots. In the United States, Xarelto is indicated for the prophylaxis of deep vein thrombosis (DVT), which can lead to pulmonary embolism (PE) in people undergoing knee or hip replacement surgery, and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. There are limited data on the relative effectiveness of Xarelto and warfarin in reducing the risk of stroke and systemic embolism in nonvalvular atrial fibrillation patients when warfarin therapy is well-controlled.

Additionally, Xarelto is being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. By the time of its completion, more than 75,000 patients will have participated in the rivaroxaban clinical development program. Rivaroxaban is being developed jointly by JRD and Bayer HealthCare. U.S. marketing rights for Xarelto are held by Janssen Pharmaceuticals Inc.

For more information: www.xarelto-us.com, www.nejm.org