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Published on 4 August 2011

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Breakthrough drug gains approval for stroke prevention

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The European Commission (EC) today approved Boehringer Ingelheim’s breakthrough oral anticoagulant, Pradaxa® (dabigatran etexilate), for the prevention of stroke in patients with atrial fibrillation (AF) at risk of stroke.

This EU label extension means that, for the first time in over 50 years, millions of AF patients across Europe will have access to a new treatment for the prevention of AF-related strokes, which is effective and convenient, and has demonstrated a good safety profile.

The EC has approved the use of dabigatran etexilate in the EU for the prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors.

While overall the 150mg bid dose is recommended for the majority of patients, the110mg bid dose is specifically available for elderly patients aged 80 years or above, for patients at increased risk of bleeding and for patients who are co-administered with dabigatran etexilate and the calcium channel blocker verapamil.

In 2008, dabigatran etexilate was granted EU approval for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or elective total knee replacement surgery.

Speaking of the new EU label extension for the prevention of stroke in patients with AF, Professor Gregory Lip, Consultant Cardiologist & Professor of Cardiovascular Medicine at the University of Birmingham Centre for Cardiovascular Sciences in the 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 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.”

Trudie Lobban, from the Atrial Fibrillation Association, added:

“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.”

Boehringer Ingelheim



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