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EU approval for Boehringer’s Pradaxa

Boehringer-Ingelheim’s Pradaxa (dabigatran etexilate) has become the first drug in 50 years to gain EU approval for stroke prevention in atrial fibrillation (AF)
Boehringer-Ingelheim's oral direct thrombin inhibitor Pradaxa (dabigatran etexilate) has been approved by the European Commission for the prevention of stroke in patients with atrial fibrillation (AF) at risk of stroke.

Although the anticoagulant is already licensed for this indication in the US, Canada, Japan, Australia and elsewhere, dabigatran etexilate has only previously been approved in Europe for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or elective total knee replacement surgery.

This new approval – which is specifically 'for the prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors' – makes Pradaxa the first drug in 50 years to receive approval in Europe for the prevention of stroke in AF. 

Professor Gregory Lip, consultant cardiologist and professor of cardiovascular medicine at the University of Birmingham Centre for Cardiovascular Sciences, Birmingham, UK, said: “The approval of dabigatran etexilate in Europe represents a major advance in the treatment of this condition. For the past 50 years physicians worldwide have been waiting for an alternative to vitamin K antagonist therapies, such as the long time standard of care, warfarin. Whilst effective, warfarin has many limitations […] resulting in only half of eligible patients receiving warfarin and fewer than half of these patients being controlled within the desired therapeutic range.”

The label extension of dabigatran etexilate is based on the results of the RE-LY study, a prospective, randomised open-label trial with blinded endpoint evaluation, which examined over 18,000 patients receiving warfarin, 110mg BID dabigatran etexilate or 150mg BID dabigatran etexilate. 

In the study, the 150mg BID dose of dabigatran etexilate was shown to reduce the risk of stroke and systemic embolism by 35 per cent, compared with warfarin. This makes dabigatran etexilate the only novel oral anticoagulant to have been proved to be superior to warfarin. Additionally, the 110mg dose was shown to be non-inferior to warfarin in terms of stroke prevention. This increase in stroke prevention applied to all patients, regardless of age, gender, type of AF, prior stroke or co-morbidities, including hypertension and diabetes. 

8th August 2011

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