Boehringer Ingelheim updates US labelling of Pradaxa for stroke

Independent German drug major Boehringer Ingelheim has updated the US prescribing information for Pradaxa (dabigatran etexilate) in alignment with the US Food and Drug Administration to affirm that “Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin.”

The company says this positive change to the US label is based on 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

“Ischemic strokes account for up to 92% of strokes suffered by patients with atrial fibrillation, often leading to severe debilitation and poor prognosis,” said Hans-Christoph Diener, professor and chairman, Department of Neurology, University Duisburg-Essen, Germany. “For patients with atrial fibrillation, reducing the risk of stroke, especially ischemic stroke, is the primary goal of anticoagulation treatment. It is important for both physicians and patients to have a treatment option that offers this decisive clinical benefit over warfarin when considering long term prevention from stroke,” he added.