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news.Boehringer Ingelheim has received approval from the Ministry of Health, Labour and Welfare in Japan for Prazaxa as the ischemic stroke and systemic embolism prevention drug in patients with non-valvular atrial fibrillation (AF).
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The approval is based on Prazaxa RE-LY trial, which demonstrated reduction in risk of stroke and systemic embolism by 35% beyond the reduction achieved with well controlled warfarin (median TTR 67 %), the long-time standard of care, in addition to reductions in life-threatening and intracranial bleeding.
Boehringer Ingelheim Medicine corporate senior vice president Klaus Dugi said the approval of dabigatran etexilate for stroke prevention in AF in Japan is a very important step towards the goal to make this treatment available to all patients with AF at risk of stroke.
"We look forward to working with regulatory authorities worldwide regarding the approval of this breakthrough therapy," Dugi said.