U.S. approval for anticoagulant

The U.S. Food and Drug Administration (FDA) has approved Xarelto™ (active ingredient: rivaroxaban) for the prevention of deep vein thrombosis (DVT) in people undergoing knee or hip replacement surgery. This makes Xarelto™ the first novel once-daily anticoagulant in tablet form to be approved in this indication in the United States.

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 and travels through the bloodstream to the lungs, it may block a blood vessel there. This condition, known as a pulmonary embolism, may impact the flow of oxygenated blood, with potentially life-threatening consequences.

“The approval of once-daily Xarelto™ tablets now extends to the United States a new option to help protect patients from developing venous blood clots following knee or hip replacement surgery,” said Dr. Louis M. Kwong, Professor of Orthopedic Surgery at Harbor-UCLA Medical Center, who was involved with the Xarelto™ clinical trials program in this indication. “Xarelto™ has a proven clinical benefit over the current treatment standard for preventing these potentially life-threatening blood clots, and the use of a once-daily tablet may greatly simplify clinical practice.”

Rivaroxaban is the most studied oral, direct Factor Xa inhibitor in the world today. By the time of its completion, more than 65,000 patients will have participated in the rivaroxaban clinical development program, which is evaluating this compound for the prevention and treatment of a broad range of acute and chronic thromboembolic disorders.