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Dabigatran is a direct thrombin inhibitor that is approved for the prevention of stroke in atrial fibrillation and for the treatment of venous thromboembolism. Bleeding is usually managed by discontinuing the drug or, if severe, by giving a prothrombin complex concentrate. However, a specific antidote would be required if more urgent reversal of the drug were needed.
Now, researchers have developed a monoclonal antibody fragment, idarucizumab, which tightly binds to dabigatran and nullifies its anticoagulant activity. The agent has now been evaluated in two studies: a randomized, placebo-controlled, double-blind, proof-of-concept phase 1 study in healthy male volunteers, and a prospective cohort trial in patients requiring urgent reversal be…