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Priority review for stroke drug

The US FDA has granted priority review for Boehringer Ingelheim's dabigatran etexilate for the prevention of stroke in patients with atrial fibrillation

The US Food and Drug Administration (FDA) has granted priority review for Boehringer Ingelheim's oral direct thrombin inhibitor dabigatran etexilate for the prevention of stroke in patients with atrial fibrillation (AF).

Therapies qualify for priority review if they offer major advances in treatment, or provide a treatment where no adequate therapy exists.

The decision is based on the results of the phase III RE-LY study (Randomised Evaluation of Long-term anticoagulant therapY), which compared the safety and efficacy of dabigatran etexilate with current therapy, warfarin.

These results showed dabigatran etexilate significantly reduced the risk of stroke and systemic embolism in patients with AF by 34 per cent compared to warfarin.

Boehringer's drug also had fewer side-effects than warfarin, showing a reduction in haemorrhagic stroke as well as intracranial and total bleeding.

Professor Jonas Oldgren, associate professor of cardiology, Uppsala Clinical Research Centre, one of the coordinating centres in RE-LY, said: "Dabigatran etexilate is the first treatment to significantly reduce stroke in patients with atrial fibrillation across all risk groups, when compared to well-controlled warfarin. This novel direct thrombin inhibitor could represent a very important advance in the prevention of stroke in patients with AF for both healthcare professionals and patients alike."

An advisory committee for the FDA will meet on September 20 to further review dabigatran etexilate data.

The drug is also under review by the region's respective regulatory bodies in Europe and Japan, with Boehringer expecting to receive initial marketing authorisation for dabigatran etexilate at end of 2010 or beginning of 2011.

31st August 2010

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