FDA assigns Priority Review designation to JRD's XARELTO sNDA

Feb 27 2012

Janssen Research & Development, LLC (JRD) announced today that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for XARELTO^® (rivaroxaban), 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), 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 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 that were presented in November 2011 at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine (10.1056/NEJMoa1112277).

SOURCE Janssen Research & Development, LLC