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FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation
Date:10/19/2010

RIDGEFIELD, Conn., Oct. 19 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate) capsules to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib).(1)  PRADAXA, an oral direct thrombin inhibitor(2) that was discovered and developed by Boehringer Ingelheim, is the first new oral anticoagulant approved in the U.S. in more than 50 years.  As demonstrated in the RE-LY® trial, PRADAXA 150mg taken twice daily has been shown to significantly reduce stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin,(1) the current standard of care for patients with non-valvular atrial fibrillation. PRADAXA 150mg taken twice daily significantly reduced both ischemic and hemorrhagic strokes compared to warfarin.(1)  

The FDA approval of PRADAXA(1) provides a new treatment to reduce the risk of stroke for the increasing number of patients with AFib.(3)  The safety and efficacy profile of PRADAXA was established based on the results of the 18,113 patient RE-LY® trial, the largest stroke prevention trial in AFib patients completed to date.(4) Treatment with PRADAXA does not require blood monitoring or related dose adjustments and has no recommended dietary restrictions.(1)  The FDA also approved PRADAXA 75mg twice daily for the small subset of patients who have severe renal impairment.(1)  

"For many years, physicians have been searching for new options to reduce the risk of stroke faced by millions of patients with atrial fibrillation. Many of these patients are either not receiving anticoagulation therapy or are taking it sub-optimally, placing them at risk for stroke or major bleeding," explained Jonathan L. Halperin, M.D., Director of Clinical Cardiology Services, Mount Sinai Medical Center.  "Pradaxa represents an exciting new treatment option for patients with non-valvular atrial
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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