Boehringer Ingelheim announced that the FDA has approved Pradaxa (dabigatran etexilate capsules), an oral direct thrombin inhibitor, to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib). This approval was based on data from the Phase 3 RE-LY trial conducted on 18,113 patients that showed that Pradaxa 150mg taken twice daily significantly reduced stroke and systemic embolism by 35% beyond the reduction achieved with warfarin in patients with AFib. Pradaxa 150mg taken twice daily also significantly reduced both ischemic and hemorrhagic strokes compared to warfarin.

Pradaxa is expected to be available in the coming weeks in 75mg and 150mg dosage strengths.

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