Anti-Dabigratan (Idarucizumab), Humanized Antibody

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The research-grade biosimilar antibody is a humanized monoclonal antibody fragment that specifically neutralizes the anti-coagulatory effect of dabigatran. Dabigatran is a non-peptidic inhibitor of thrombin (Factor IIa) that plays an important role in blood coagulation. Dabigatran and its acyl glucuronide metabolites bind reversibly with thrombin and inhibit its coagulatory activity. The antibody binds to thrombin-bound dabigatran and its metabolites in a 1:1 ratio with very high affinity (≈ 350-fold higher than dabigatran affinity for thrombin) and thus prevents thrombin inhibition. The original drug was approved by the FDA to treat patients requiring emergency surgery or having an uncontrolled bleeding condition