Janssen Research & Development Submits Application to US FDA for XARELTO®
02-Jan-2012
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RARITAN, NJ - Janssen Research & Development, LLC (JRD) announced in a press release that it has submitted a supplemental New Drug Application (sNDA) to the US 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/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 (10.1056/NEJMoa1112277).
ACS is a complication of coronary heart disease, which is the leading cause of death in the US 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 US 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.