FDA expands Xarelto's indication for DVT, PE

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The FDA has expanded the approved use of rivaroxaban (Xarelto, Janssen Pharmaceuticals) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE) and to reduce the risk of recurrent DVT and PE following initial treatment.

In July 2011, rivaroxaban was FDA approved to reduce the risk of DVTs and PEs from occurring after knee or hip replacement surgery, and in November 2011 it was approved to reduce the risk of stroke in people who have non-valvular atrial fibrillation.

The FDA reviewed Xarelto’s new indication under the agency’s 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 anticlotting 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 Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Other drugs approved by FDA to treat or reduce the risk of blood clots include enoxaparin (Lovenox, Sanofi), generic versions of enoxaparin, fondaparinux (Arixtra, GlaxoSmithKline),  dalteparin (Fragmin, Eisai), warfarin and heparin.

The agency noted that 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, or a placebo. The studies were designed to measure the number of patients who experienced recurrent symptoms of DVT, PE or death after receiving treatment. The major side effect observed with Xarelto is bleeding, similar to other anticlotting drugs.