Boehringer Ingelheim Corporation Release: FDA Affirms Superiority of Pradaxa® (dabigatran etexilate) 150 Mg Over Warfarin in Reduction of Both Ischaemic and Haemorrhagic Strokes

Published: Jun 06, 2012

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim has today announced that it has updated the US prescribing information for Pradaxa® (dabigatran etexilate) in alignment with the US Food and Drug Administration (FDA) to affirm that “Pradaxa® 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin.”1 This positive change to the US label is based upon the results of the pivotal RE-LY® trial conducted in 18,000 patients with non-valvular atrial fibrillation, which demonstrated unequivocally the superior benefits offered by Pradaxa® in terms of effective prevention of stroke. In addition, RE-LY® demonstrated a significant benefit versus well controlled warfarin in life-threatening bleeding events, and major reductions in intracranial bleeding.2,3,‡

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