FDA Expands Use of Xarelto to Treat, Reduce Recurrence of Blood Clots
November 2, 2012 -- The U.S. Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.
Blood clots occur when blood thickens and clumps together. DVT is a blood clot that forms in a vein deep in the body. Most deep vein blood clots occur in the lower leg or thigh. When a blood clot in a deep vein breaks off and travels to an artery in the lungs and blocks blood flow, it results in a potentially deadly condition called PE.
Xarelto is already FDA-approved to reduce the risk of DVTs and PEs from occurring after knee or hip replacement surgery (July 2011), and to reduce the risk of stroke in people who have a type of abnormal heart rhythm called non-valvular atrial fibrillation (November 2011).
The FDA reviewed Xarelto’s new indication under the agency’s priority review program, which provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.
“Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Other drugs approved by FDA to treat or reduce the risk of blood clots include Lovenox (enoxaparin), generic versions of enoxaparin, Arixtra (fondaparinux), Fragmin (dalteparin), Coumadin (warfarin), and heparin.
The safety and effectiveness of Xarelto for the new indications were evaluated in three clinical studies. A total of 9,478 patients with DVT or PE were randomly assigned to receive Xarelto, a combination of enoxaparin and a vitamin K antagonist (VKA), or a placebo. The studies were designed to measure the number of patients who experienced recurrent symptoms of DVT, PE or death after receiving treatment.
Results showed Xarelto was as effective as the enoxaparin and VKA combination for treating DVT and PE. About 2.1 percent of patients treated with Xarelto compared with 1.8 percent to 3 percent of patients treated with the enoxaparin and VKA combination experienced a recurrent DVT or PE. Additionally, results from a third study showed extended Xarelto treatment reduced the risk of recurrent DVT and PE in patients. About 1.3 percent of patients treated with Xarelto compared with 7.1 percent of patients receiving placebo experienced a recurrent DVT or PE.
The major side effect observed with Xarelto is bleeding, similar to other anti-clotting drugs.
Xarelto is marketed by Raritan, N.J.-based Janssen Pharmaceuticals Inc.
Posted: November 2012
- FDA Approves Xarelto (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients - October 14, 2019
- FDA Approves Xarelto to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD) - October 11, 2018
- FDA Approves New 10 mg Dosing for Xarelto (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE) - October 30, 2017
- FDA Issues Complete Response Letter for Xarelto (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome - June 28, 2013
- FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm - November 4, 2011
- FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery - July 1, 2011
- New Drug Application Submitted to FDA for Rivaroxaban for Prevention of Stroke in Patients with Atrial Fibrillation - January 5, 2011
- New Drug Application for Rivaroxaban in the U.S. - July 16, 2009
- U.S. FDA Issues Complete Response Letter for Rivaroxaban - May 28, 2009
- FDA Advisory Committee Finds Favorable Risk-Benefit Profile for Oral Anticoagulant Rivaroxaban for Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism After Hip or Knee Replacement Surgery - March 20, 2009
- Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S. - July 30, 2008
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