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The National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has issued a Final Appraisal Determination (FAD) recommending the novel oral anticoagulant, Pradaxa® (dabigatran etexilate), as a treatment option without any restrictions within its licensed indication for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation (AF) with one or more risk factors.
The FAD will form the guidance to the National Health Service (NHS) in England and Wales, which is expected to be published in December.
The novel oral anticoagulant Pradaxa® has been approved for this indication in more than 50 countries worldwide (including the U.S., Canada, Japan and the member states of European Union).
Since the first launch of Pradaxa® in this new indication in October 2010, more than 450,000 patients have already been prescribed Pradaxa®.
“Boehringer Ingelheim welcomes today’s recommendation by NICE, which once again confirms that Pradaxa® is both clinically effective and cost-effective in stroke prevention in AF,” said Prof. Dr. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.
“The NICE FAD is another important step forward to make this innovative new anticoagulant treatment option available to eligible patients with AF and to help protect more patients from the potentially devastating effects of an AF-related stroke.”
Pradaxa® was the first novel oral anticoagulant approved for stroke prevention in AF since the current standard of care warfarin was made available approximately 55 years ago.
The approvals were based on the landmark RE-LY® trial, which compared two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin in a PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial design.