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FDA Expands Use of Xarelto (Rivaroxaban) to Treat, Reduce Recurrence of Blood Clots

First drug approved for this indication in nearly 60 years (Nov. 2)

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

Xarelto is already FDA-approved to reduce the risk of DVTs and PEs after knee- or hip-replacement surgery (July 2011), and to reduce the risk of stroke in patients with non-valvular atrial fibrillation (November 2011).

The FDA reviewed Xarelto’s new indication under the agency’s priority review program, which provides an expedited 6-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.

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.

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

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 placebo. The studies were designed to measure the number of patients who experienced recurrent symptoms of DVT or PE, or death, after receiving treatment.

The results showed that Xarelto was as effective as the combination of enoxaparin and VKA for treating DVT and PE. About 2.1% of patients treated with Xarelto compared with 1.8% to 3.0% of patients treated with enoxaparin and VKA experienced a recurrent DVT or PE. In addition, results from a third study showed that extended Xarelto treatment reduced the risk of recurrent DVT and PE. About 1.3% of patients treated with Xarelto compared with 7.1% of patients receiving placebo experienced a recurrent DVT or PE.

Source: FDA; November 2, 2012.

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