The oral anticoagulant rivaroxaban has been approved for the treatment of deep vein thrombosis or pulmonary embolism and for reducing the recurrence of DVT and PE after initial treatment, the Food and Drug Administration announced Nov. 5.
The expanded approval was based on the results of three studies of almost 9,500 patients with a DVT or PE which found that treatment with rivaroxaban was as effective as the combination of the low molecular weight heparin enoxaparin and a vitamin K antagonist in treating DVT and PE. In one of the studies, continued treatment with rivaroxaban reduced the risk of recurrent DVT and PE, according to an FDA statement.
Rivaroxaban, a factor Xa inhibitor, was initially approved in July 2011 for prophylaxis of DVT or PE in patients undergoing hip replacement or knee-replacement surgery, at a dose of 10 mg orally once a day. Marketed as Xarelto by Janssen Pharmaceuticals, it received in November 2011 a second indication for reducing the risk of stroke in patients with nonvalvular atrial fibrillation.
The FDA is currently reviewing the company’s applications to approve rivaroxaban for reducing the risk of stent thrombosis in patients with acute coronary syndrome and for reducing the risk of secondary cardiovascular events in patients with ACS, according to Janssen.