Janssen Research & Development announced that the FDA has assigned a priority review designation to the supplemental New Drug Applications (sNDAs) for Xarelto (rivaroxaban) seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent recurrent DVT and PE.
The submissions are supported by data from the global EINSTEIN program, which includes two Phase 3 studies evaluating the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent events in these patients. A third Phase 3 study evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent DVT and PE. In total, these Phase 3 studies included more than 9,400 patients.
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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