The FDA ( Food and Drug Administration ) has 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.
Deep vein thrombosis 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 pulmonary embolism.
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 Xareltos new indication under the agencys 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.
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 deep vein thrombosis, pulmonary embolism or death after receiving treatment.
Results have showed Xarelto was as effective as the Enoxaparin and vitamin K antagonist combination for treating deep vein thrombosis and pulmonary embolism. About 2.1% of patients treated with Xarelto compared with 1.8 to 3% of patients treated with the Enoxaparin and vitamin K antagonist combination experienced a recurrent deep vein thrombosis or pulmonary embolism.
Additionally, results from a third study showed extended Xarelto treatment reduced the risk of recurrent deep vein thrombosis and pulmonary embolism in patients. About 1.3% of patients treated with Xarelto compared with 7.1% of patients receiving placebo experienced a recurrent deep vein thrombosis or pulmonary embolism.
The major side effect observed with Xarelto is bleeding, similar to other anti-clotting drugs.
Source: FDA, 2012