Pradaxa (dabigatran Etexilate) Gains European Approval For Stroke Prevention In Atrial Fibrillation

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Main Category: Heart Disease
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 04 Aug 2011 - 14:00 PDT


EMA (European Medicines Agency) has approved Pradaxa (dabigatran etexilate) for stroke prevention in individuals with AF (atrial fibrillation) who are at risk of stroke. This is the first stroke prevention drug in 50 years for patients with atrial fibrillation, Pradaxa makers, Boehringer Ingelheim informed.

Dabigatran etexilate has been approved specifically for adults with non-valvular AF with at least one risk factor.

A 150mg bid dose is aimed at the majority of patients, and 110mg bid for those aged at least 80 years, for those with an elevated risk of bleeding, and patients receiving combination dabigatran etexilate and the calcium channel blocker verapamil.

Dabigatran etexilate was approved in 2008 in Europe for the prevention of blood clots in adults who had had elective total hip or elective total new replacement surgery.

Professor Gregory Lip, Consultant Cardiologist & Professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, Birmingham, United Kingdom commented, 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 long time standard of care, Warfarin. Whilst effective, warfarin has many limitations such as the need for regular monitoring and various food-drug and drug-drug interactions, resulting in only half of eligible patients receiving warfarin and fewer than half of these patients being controlled within the desired therapeutic range."

Atrial Fibrillation Association CEO, Trudie Lobban, said:

"Atrial fibrillation raises the risk of stroke by five times, resulting in up to three million people worldwide suffering strokes related to this condition each year. Atrial fibrillation-related strokes are particularly severe and disabling, with one half of this population dying within one year after a stroke."

European regulatory authorities approved dabigatran etexilate after reviewing data on the RE-LY study, involving 18,000 patients with AF. RE-LY was a prospective, randomized, open-label with blinded endpoint evaluation trial, which compared two doses of the oral direct thrombin inhibitor dabigatran etexilate with open label Warfarin.

Dr. Stuart Connolly, co-principal investigator of RE-LY, Director, Division of Cardiology at McMaster University and member of The Population Health Research Institute, Hamilton, Ontario said:

"The landmark RE-LYstudy results also showed us that dabigatran etexilate is consistently effective at preventing strokes across a wide range of patients with AF, irrespective of age, gender, stroke risk, type of atrial fibrillation, prior stroke, and comorbidities such as hypertension and diabetes."

Dabigatran etexilate has already been approved by regulatory authorities for stoke prevention for atrial fibrillation patients in Australia, Japan, Canada and the USA, as well as other countries.

Professor Andreas Barner,Chairman of the Board of Managing Directors, Boehringer Ingelheim, said:

"The approval of dabigatran etexilate in Europe marks an important milestone in the history of Boehringer Ingelheim and also in the continuing fight for improved prevention of stroke, a disease which continues to have a large unmet need. It is a result of nearly 20 years of innovative research and development by our scientists. We will now ensure that this new breakthrough treatment is made available to physicians and atrial fibrillation patients throughout Europe as soon as possible."

Written by: Christian Nordqvist


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