Rivaroxaban (Xarelto) can be marketed for treatment of acute deep vein thrombosis (DVT) and pulmonary embolism and for prevention of recurrences, the FDA announced late Friday.
These indications are in addition to the drug's previous approvals for prevention of thromboembolism and stroke in patients with nonvalvular atrial fibrillation and for DVT prevention in patients undergoing joint surgery.
Rivaroxaban "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, MD, director of the FDA's Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research, in an agency statement.
The approval was based mainly on results from three trials with a total of 9,478 patients randomized to rivaroxaban, placebo, or enoxaparin (Lovenox) combined with a vitamin K antagonist such as warfarin (Coumadin).
Those trials showed that rivaroxaban "was as effective as the enoxaparin and vitamin K antagonist combination for treating DVT and pulmonary embolism," the FDA said.
A placebo-controlled trial showed that 1.3% of patients taking rivaroxaban had recurrent thromboembolic events compared with 7.1% of those assigned to placebo.
The studies also indicated that rivaroxaban has a lower risk of bleeding events. For example, in the EINSTEIN-PE trial, reported earlier this year in the New England Journal of Medicine and at the American College of Cardiology's annual meeting, 1.1% of patients on rivaroxaban had major bleeding versus 2.2% with enoxaparin (P=0.003).
A major advantage of rivaroxaban, an oral Factor Xa inhibitor, is that it doesn't require the close monitoring of coagulation activity needed with heparin and its analogs.
Its major adverse event is increased risk of bleeding, as is the case with other anticoagulant drugs, the FDA noted.
The drug was approved in Europe last December for prevention of recurrent deep vein thrombosis and pulmonary embolism in patients who've had a deep vein thrombosis.
Rivaroxaban is marketed in the U.S. by Janssen Pharmaceuticals of Raritan, N.J.