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FDA to review dabigatran for indications for DVT, PE

Issue: October 10, 2013

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Boehringer Ingelheim recently announced that the FDA has agreed to review dabigatran for use in patients with deep vein thrombosis and pulmonary embolism.

Dabigatran (Pradaxa), an oral anticoagulant, is currently approved to reduce the risk for stroke and symbolic embolism in patients with non-valvular atrial fibrillation.

According to a company press release, the submission includes results from four phase 3 studies evaluating dabigatran in patients with DVT or PE: RE-COVER I, RE-COVER II, RE-MEDY and RE-SONATE.

There are approximately 900,000 venous thromboembolism events, including DVT and PE, per year in the United States, about one-third of which result in PE-related death, according to information from the press release.