FDA approves rivaroxaban for DVT after hip/knee surgery

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The FDA has approved Xarelto (rivaroxaban, Janssen Pharmaceuticals), a once-daily, oral anticoagulant for the prevention of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery.

The American College of Chest Physicians recommends the use of 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 re-hospitalization following joint replacement surgery.

Pivotal data from the Xarelto 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 (five weeks) rivaroxaban with short-duration (two weeks) enoxaparin, followed by placebo, according . 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 globally and in more than 80 countries by Bayer HealthCare. Janssen Pharmaceuticals holds marketing rights for Xarelto in the U.S. The U.S. Bayer HealthCare sales force will support the Janssen Pharmaceuticals salesforce by detailing Xarelto in designated hospital accounts.