The FDA has voted in favor of expanding indications for rivarobaxan (Xarelto, Janssen) to include deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment, the agency announced.
The drug was previously approved to prevent thromboembolism and stroke in patients with with nonvalvular atrial fibrillation and for DVT prevention in patient’s undergoing joint surgery.
“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,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said in a press release.
The approval was based on findings from three clinical trials involving 9,478 patients randomized to rivaroxaban, placebo, or enoxaparin (Lovenox) combined with a vitamin K antagonist such as warfarin (Coumadin), that showed that rivaroxaban was as effective as enoxaparin and vitamin K antagonists combined for treating DVT and PE.
Additionally results from a placebo-controlled trial showed that 1.3% of patients treated with Xarelto experienced a recurrent DVT or pulmonary embolism compared with 7.1% of patients receiving placebo.
Major adverse events include increased risk of bleeding, as is the case with other anticoagulant drugs, the FDA noted.