Janssen announced that the FDA has approved Xarelto (rivaroxaban), an oral anticoagulant, for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE following initial treatment. Xarelto is the first oral anticoagulant approved to treat these conditions without the need for injections or routine blood monitoring, and was approved on a priority review timeline.
The approvals for these three new uses were based on data from the global EINSTEIN program, which included two Phase 3 studies evaluating the safety and efficacy of Xarelto in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent, symptomatic DVT and PE. A third Phase 3 study evaluated the safety and efficacy of Xarelto in the long-term prevention of recurrent symptomatic DVT and PE. In total, these Phase 3 studies enrolled more than 9,400 patients.
Xarelto is a Factor Xa inhibitor already indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and in prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery.
For more information call (800) JANSSEN or visit www.xareltohcp.com.