News | July 05, 2011

FDA Approves Xarelto Oral Anticoagulant

July 5, 2011 — Janssen Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban tablets), a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT), which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.

"The approval of once-daily Xarelto tablets will provide a new option to help protect patients from developing venous blood clots following knee or hip replacement surgery," said Louis M. Kwong, M.D., professor of orthopedic surgery at Harbor-UCLA Medical Center, who was involved with the rivaroxaban clinical trials program in this indication. "Xarelto has a proven clinical benefit over one of today's most widely used options in preventing these potentially life-threatening blood clots, and the use of a once-daily pill may play an essential role in helping to simplify clinical practice."

According to the American Academy of Orthopedic Surgeons, more than 800,000 Americans undergo knee or hip replacement surgery each year. These procedures are associated with an increased risk for DVT, a blood clot that forms in a deep vein, usually in the leg. If all or part of a DVT breaks off, it can travel to the lungs and become a PE, where it may impact the flow of oxygenated blood and lead to potentially life-threatening consequences.

The American College of Chest Physicians recommends the use of blood thinners (anticoagulants) immediately following major orthopedic replacement surgery and extended use post-discharge (at least 10 days for knee replacement, and up to 35 days for hip replacement) to help reduce such risks; however, full compliance with these guidelines using previously available options has not been widely observed. DVT and PE are the leading causes of rehospitalization following joint replacement surgery.

Pivotal data from the Phase 3 clinical development program reflected in the approved label showed significantly greater efficacy of rivaroxaban, both in head-to-head comparison with enoxaparin and when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin, followed by placebo. In these trials, rivaroxaban and enoxaparin demonstrated similar safety profiles, including low rates of major bleeding.

Xarelto is approved for use at a 10 mg dose, once-daily for 35 days following hip replacement and for 12 days following knee replacement surgery. To date, Xarelto is approved in more than 110 countries worldwide and has been successfully launched in more than 80 countries by Bayer HealthCare. Janssen Pharmaceuticals, Inc. holds marketing rights for Xarelto in the U.S.

For more information: www.janssenpharmaceuticalsinc.com

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