Janssen Research & Development submits supplemental new drug application to FDA for rivaroxaban

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Janssen Research & Development has announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of rivaroxaban (Xarelto) to reduce the risk of stent thrombosis in patients with acute coronary syndrome. 

The oral anticoagulant is currently is under review with the FDA to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome and it is already approved in the US 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 haemorrhagic 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.


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.