Janssen submits XARELTO sNDA with FDA to reduce risk of stent thrombosis in ACS patients

Janssen Research & Development, LLC (Janssen) 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 stent thrombosis in patients with Acute Coronary Syndrome (ACS). XARELTO^® currently is under review with the U.S. FDA to reduce the risk of secondary cardiovascular events in patients with ACS. XARELTO^® already is approved in the U.S. to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, and to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.

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 2011 at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine (10.1056/NEJMoa1112277).

In the trial, the 2.5 mg twice-daily (BID) dose of rivaroxaban was associated with a 35% Relative Risk Reduction in the rate of stent thrombosis compared to placebo [2.2% vs. 2.9% (Hazard Ratio: 0.65; Confidence Interval: 0.45-0.94)]. Rates of TIMI (Thrombolysis In Myocardial Infarction) major bleeding events not associated with coronary artery bypass graft surgery were low overall in the trial, but rivaroxaban was associated with higher rates of these bleeds in the 2.5 mg BID dose compared to placebo [1.8% vs. 0.6% (Hazard Ratio: 3.46; Confidence Interval: 2.08-5.77)]. Importantly, these differences were not associated with an excess risk of fatal bleeding. Additional data on stent thrombosis, from the ATLAS ACS 2 TIMI 51 trial, will be presented later this year.