The approved use of Xarelto (rivoraxaban) has been expanded to include the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), and the reduction of 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, and when this clots breaks off and travels to an artery in the lungs, it blocks blood flow resulting in a potentially lethal condition called PE.
In November 2011, Xarelto gained FDA approval as a means of reducing the risk of stroke in people who have a type of abnormal heart rhythm called non-vulvular atrial fibrillation. After gaining today’s approval, Xarelto is now the first oral anti-coagulant approved to reduce the recurrence of blood clots since warfarin was approved nearly 60 years ago. Other drugs approved by the FDA to treat or reduce the risk of blood clots include Lovenox (fraxiparin) and generics, 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% of patients treated with Xarelto compared with 1.8% to 3% 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% of patients treated with Xarelto compared with 7.1% 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.