Pradaxa capsules receive FDA approval for reducing stroke and systemic embolism risk in AFib patients

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). PRADAXA, an oral direct thrombin inhibitor 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, 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.  

The FDA approval of PRADAXA provides a new treatment to reduce the risk of stroke for the increasing number of patients with AFib. 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. Treatment with PRADAXA does not require blood monitoring or related dose adjustments and has no recommended dietary restrictions.  The FDA also approved PRADAXA 75mg twice daily for the small subset of patients who have severe renal impairment.

"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 fibrillation."

Warfarin, first approved in the 1950s, has been the standard of care and the only oral anticoagulant available in the U.S. for stroke reduction in patients with AFib.  Warfarin is efficacious in reducing the risk of stroke in patients with AFib when within its narrow therapeutic range.  In addition, it has the potential for interactions with many commonly used medications, as well as certain foods. As a result, patients taking warfarin must maintain a consistent diet and have their INR monitored and managed through regular blood tests and dose adjustments.

"This is a special moment which exemplifies innovation in modern medicine.  We are thrilled that the FDA's approval of PRADAXA will bring a novel medicine to patients with non-valvular atrial fibrillation," said Albert Ros, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc.  "This approval marks a proud moment in our company's 125-year history and is a shining example of how Boehringer Ingelheim is dedicated to innovating, developing and providing treatments to improve the lives of patients."