Xarelto Approved to Treat DVT and PE, Reduce Risk of Recurrent Events

November 2, 2012—Janssen Pharmaceuticals, Inc. (Titusville, NJ) announced that the US Food and Drug Administration 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 approved to treat DVT and PE without the need for injections or routine blood monitoring; it was approved for these three new indications on a priority review timeline of 6 months, the company noted.

“Xarelto provides a single-drug treatment option from the moment of diagnosis through the completion of therapy, and in the initial treatment phase, it can cut a patient's risk of major bleeding by nearly half,” stated Jack E. Ansell, MD, in the company's press release. Dr. Ansell is Professor of Medicine at New York University School of Medicine and Chairman of the Department of Medicine at Lenox Hill Hospital in New York City. “Venous blood clots are associated with a high risk of serious complications, so the approval of Xarelto will immediately impact how we treat these patients and may set a new standard of care,” he said.



The company stated that Xarelto is approved to treat patients with DVT or PE at a dose of 15 mg twice daily for 3 weeks, followed by 20 mg once daily for the remaining treatment period. Xarelto also is approved to reduce the risk of recurrence of DVT and PE at a dose of 20 mg once daily following an initial 6 months of treatment for acute venous thromboembolism.


According to Janssen, the approval of Xarelto 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 included more than 9,400 patients.

Janssen advised that Xarelto does not require routine blood monitoring, and is approved for six distinct uses: (1) To reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery; (2) to reduce the risk of blood clots in the legs and lungs of people who have just had hip replacement surgery; (3) to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem (Janssen noted that there is limited information on how Xarelto compares to warfarin in reducing the risk of stroke when the effects of warfarin are well controlled); (4) to treat people with PE; (5) to treat people with DVT; and (6) to reduce the risk of recurrence of DVT or PE after an initial 6 months of treatment for acute venous thromboembolism.

Rivaroxaban is being jointly developed by Janssen Research & Development, LLC (Raritan, NJ) and Bayer HealthCare (Leverkusen, Germany). In the United States, Janssen Pharmaceuticals holds the marketing rights for Xarelto. Janssen R&D and Janssen Pharmaceuticals are part of the Janssen Pharmaceutical Companies of Johnson & Johnson (New Brunswick, NJ).