FDA Approves Xarelto for Prevention of DVT After Hip and Knee Replacement Surgery

July 1, 2011—Janssen Pharmaceuticals, Inc. (Titusville, NJ), a Johnson & Johnson company, announced that the US Food and Drug Administration has approved Xarelto (rivaroxaban tablets), a once-daily, oral anticoagulant, for the prophylaxis of deep vein thrombosis that may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery. Xarelto works by blocking the blood-clotting factor Xa to reduce the tendency of blood to form clots.

According to the company, pivotal data from Xarelto's phase 3 clinical development program, as 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 showed similar safety profiles including low rates of major bleeding.
 

Xarelto is approved for use at a 10-mg dose once daily for 35 days after hip replacement and for 12 days after knee replacement surgery. To date, Xarelto is approved in more than 110 countries worldwide and is marketed in more than 80 countries by Bayer AG (Leverkusen, Germany). Janssen holds the marketing rights for Xarelto in the United States.

In December 2010, Endovascular Today reported on the publication of the EINSTEIN studies of Xarelto for the treatment of deep vein thrombosis in the New England Journal of Medicine. Endovascular Today also reported on the presentation of EINSTEIN data at the annual European Society of Cardiology Congress in Stockholm, Sweden in August 2010.