FDA Okays Expanded Indications for Rivaroxaban

Megan Brooks


November 02, 2012

The US Food and Drug Administration (FDA) today expanded the approved use of rivaroxaban (Xarelto, Bayer/Johnson & Johnson) to include treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and to reduce the risk for recurrences after initial treatment.

The factor Xa oral anticoagulant is already FDA-approved to reduce the risk for DVT and PE after knee or hip replacement surgery (July 2011) and to reduce the risk for stroke in people with nonvalvular atrial fibrillation (November 2011).

Rivaroxaban's new indication received FDA priority review, which provides an expedited 6-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists, the agency said in a statement.

"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 an agency news release.

"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," according to the release.

Rivaroxaban proved as effective as the enoxaparin (Lovenox, sanofi-aventis) and vitamin K antagonist combination for treating DVT and PE.

The FDA notes that about 2.1% of patients treated with rivaroxaban experienced a recurrent DVT or PE compared with between 1.8% and 3% of patients treated with the enoxaparin and vitamin K antagonist combination.

In addition, extended rivaroxaban treatment reduced the risk for recurrent DVT and PE in patients: About 1.3% of patients treated with rivaroxaban experienced a recurrent DVT or PE compared with 7.1% of patients receiving placebo.

The major adverse effect observed with rivaroxaban is bleeding, similar to other anticoagulant drugs.

A company press release notes that the expanded approval gives rivaroxaban the "broadest indication profile of any of the newer oral anticoagulants." It is also under review by the FDA for 2 additional indications: acute coronary syndrome and stent thrombosis. Earlier this year, the FDA declined to extend the indication to patients with acute coronary syndrome, instead asking the sponsor to provide additional data.

Rivaroxaban is marketed by Janssen Pharmaceuticals Inc.