Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS).
Xarelto is presently under review with the FDA to reduce the risk of secondary cardiovascular events in patients with ACS.
The filing is supported by data from the pivotal Phase 3 Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome trial.
FDA already approved the use of Xarelto in reducing the risk of blood clots in the legs and lungs of knee or hip replacement surgery patients and risk of hemorrhagic, thrombotic strokes and blood clots in atrial fibrillation patients, which is not caused by a heart valve problem.
