Johnson & Johnson subisidiary Janssen Pharmaceuticals has received FDA approval for Xarelto, a novel, once-daily, oral anticoagulant for the prevention of deep vein thrombosis (DVT), which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.
Pivotal data from the Xarelto Phase III clinical development program reflected in the approved label showed significantly greater efficacy of rivaroxaban, both in head-to-head comparison with enoxaparin (Lovenox) 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.
"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."
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 holds marketing rights for Xarelto in the U.S. The U.S. Bayer HealthCare sales force will support the Janssen Pharmaceuticals, Inc. sales force by detailing Xarelto in designated hospital accounts.