Boehringer Ingelheim received approval from the FDA for Pradaxa (dabigatran etexilate), an oral direct thrombin inhibitor 2 for stroke risk reduction in patients with non-valvular atrial fibrillation (AF). This is the first approval of a new oral anticoagulant in the U.S. in more than 50 years.
The approval is based on results from the RE-LY study, demonstrating that dabigatran etexilate 150 mg significantly reduced the risk of stroke and systemic embolism by 35% compared to warfarin, the standard of care, as well as reductions in life-threatening and intracranial bleeding. Dabigatran etexilate does not require monitoring or related dose adjustments, is not affected by food, and no dose adjustment is required for many common co-medications in AF patients.
Professor Andreas Barner, chairman of BI’s R&D and Medicine board, said, “This first approval of Pradaxa for stroke risk reduction in atrial fibrillation in the U.S. marks a new era for stroke prevention in atrial fibrillation. This new treatment will improve the lives of many patients and with preventing stroke, will avoid suffering for a significant proportion of them. We expect that dabigatran etexilate will in the coming months become available to patients with atrial fibrillation in more countries, internationally.”