Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Merrill Brink International

Merrill Brink International is a leading provider of life sciences, legal, financial, manufacturing and corporate language solutions for global companies....

Latest intelligence

patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe’s leading hub for life sciences innovation...

Infographics