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Boehringer Ingelheim’s novel oral anticoagulant dabigatran etexilate (to be marketed under the trademark Pradaxa®), received a positive opinion from the European Medicines Agency’s (EMA) medicinal committee today. This positive opinion is a decisive step in making the breakthrough therapy available to millions of patients with atrial fibrillation (AF) at risk of stroke in the European Union.
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of dabigatran etexilate in the member states of the EU for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors.
Dabigatran etexilate 150mg bid is the only novel oral anticoagulant proven superior to well-controlled warfarin treatment (Median TTR 67%) in reducing stroke and systemic embolism in an intention-to-treat (ITT) analysis. The ITT analysis represents the highest standard for analysing superiority in non-inferiority trials. These ground-breaking results were shown in RE-LY®, a PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial designed to compare two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin. Dabigatran etexilate 110 mg bid was shown to be as effective as warfarin. Both doses of dabigatran etexilate showed significantly lower intracranial bleeding compared to well-controlled warfarin. Dabigatran etexilate does not require routine coagulation monitoring or dose adjustments, is not affected by food and has a low potential for drug-drug interactions.
Up to three million people worldwide suffer strokes related to AF each year, which are typically severe and disabling, with one half of this population dying within one year. Strokes due to AF tend to be severe, with an increased likelihood of death (20%), and disability (60%).
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, said: “After 50 years, a more effective alternative to warfarin is finally being made available to patients. 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 significantly reducing the risk of strokes compared to warfarin and avoid immense suffering for a vast proportion of them.”
Outside the EU dabigatran etexilate has been approved for stroke risk reduction in patients with AF in the USA, Canada, Japan, South Korea, New Zealand, Israel, Malaysia, Philippines, Singapore, Namibia, Colombia, Netherlands Antilles, Suriname and Indonesia; details of these approvals may however differ from the label recommended by CHMP.
The CHMP positive opinion is based on the results from the RE-LY® trial, the largest AF trial completed to date. The data showed that dabigatran etexilate 150mg bid significantly 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.
