Heart of Health Policy | The U.S. Food and Drug Administration (FDA) has approved the anticoagulant dabigatran (Pradaxa) “for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated,” according to a press release from Boehringer Ingelheim Pharmaceuticals, Inc.

According to the release, the approval is based on results from four global Phase III studies evaluating the efficacy and safety of dabigatran in the treatment of DVT and PE: RE-COVER, RE-COVER II, RE-MEDY, and RE-SONATE. This approval expands the indications of dabigatran, which was approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation in 2010.

Keywords: Health Policy, United States Food and Drug Administration, Pulmonary Embolism, Venous Thrombosis, Cardiology Magazine, ACC Publications

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