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Ingelheim, Germany, January 21, 2011 – The Ministry of Health, Labour and Welfare in Japan today approved dabigatran etexilate, Boehringer Ingelheim’s novel, oral direct thrombin inhibitor under the brand name Prazaxa® for the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) marking the first approval of a novel oral anticoagulant in the Asia-Pacific region and specifically Japan in nearly 50 years.
Prazaxa® will be available to the approximately 830,000 AF patients at risk of stroke in Japan, with 150mg bid (given as two capsules of 75mg) recommended as the standard dose and 110mg bid available for specific patient types considered to be at a higher risk of bleeding.
The approval is based on findings from RE-LY®, the largest AF trial completed to date.
In RE-LY®, dabigatran etexilate 150 mg bid significantly reduced the risk of stroke and systemic embolism by 35% beyond the reduction achieved with well controlled warfarin (median TTR 67%), the long-time standard of care, in addition to reductions in life-threatening and intracranial bleeding.
Dabigatran etexilate is the only novel oral anticoagulant proven to be superior to warfarin and was recently approved in the U.S. and Canada.
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: “Until today, physicians in Japan have had little choice but to use warfarin, which imposes challenging restrictions on people’s quality of life. Besides being a safe and more effective alternative to warfarin, dabigatran etexilate does not require monitoring, dose adjustments and is not affected by food, which truly is a huge shift in the treatment of stroke prevention in AF.”
The approval of Prazaxa® is one of the fastest ever undertaken by the Japanese Ministry of Health, Labour and Welfare with authorisation of the novel agent gained 10 months after the filing of a new drug application.
The speed of the approval underlines the current unmet need in stroke prevention in AF in Japan and the strength of data supporting dabigatran etexilate in this indication.
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim said: “The approval of dabigatran etexilate for stroke prevention in AF in Japan is a very important step towards our goal to make this treatment available to all patients with AF at risk of stroke. It is a milestone as it marks the first approval of a novel oral anticoagulant in the Asia-Pacific region in nearly 50 years. We look forward to working with regulatory authorities worldwide regarding the approval of this breakthrough therapy.”