The Japanese regulatory authority has approved Boehringer Ingelheim’s (BI) oral direct thrombin inhibitor Prazaxa® (dabigatran etexilate), for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The firm claims the approval is the first for a novel oral anticoagulant in Japan and the Asia-Pacific region as a whole, for nearly 50 years.
Clearance was based on data from the RE-LY® study, which showed that twice-daily dabigatran reduced the risk of stroke and systemic embolism by 35% above that achieved by treatment using well-controlled warfarin and long-term standard of care.
Dabigatran is already approved in another 75 countries, trademarked either Pradaxa® or Pradax®, for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip or elective total knee replacement surgery. Pan-EU approval for Pradaxa was granted in 2008. FDA cleared the drug in September 2010 for stroke risk reduction in patients with nonvalvular atrial fibrillation. In Canada the drug is cleared for the prevention of stroke and systemic embolism in adults with atrial fibrillation. BI says approval of Prazaxa in Japan is one of the fastest ever by the Japanese Ministry of Health, Labour and Welfare. Authorization was granted just 10 months after the drug’s NDA.