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news.The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinion on Boehringer Ingelheim's oral anticoagulant dabigatran etexilate (to be marketed under the trademark Pradaxa).
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CHMP has recommended the approval for Dabigatran Etexilate in the member states of the EU as the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors.
According to Boehringer Ingelheim, CHMP’s decision was supported by the results of RE-LY trial which demonstrated that dabigatran etexilate 150mg bid reduced the risk of stroke and systemic embolism by 35% in addition to significantly lowering the risk of life-threatening and intracranial bleeding compared to well controlled warfarin.
Boehringer Ingelheim Medicine corporate senior vice president Klaus Dugi said the positive opinion from the CHMP for dabigatran etexilate represents another significant milestone in the history of stroke prevention in AF.
"When approved in the EU, dabigatran etexilate (150mg bid) will improve the lives of many patients by reducing the risk of strokes compared to warfarin and avoid immense suffering for a vast proportion of them," Dugi said.