sNDA Submitted for Xarelto for Reduction of the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome
Janssen Research & Development announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of Xarelto (rivaroxaban) to reduce the risk of stent thrombosis 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. In the trial, the 2.5mg twice-daily 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 2.5mg twice-daily 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.
Xarelto is a factor Xa inhibitor, oral anticoagulant. Xarelto already is approved to reduce the risk of blood clots in the legs and lungs of patients 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 patients with atrial fibrillation not caused by a heart valve problem.
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