PK/PD Modeling of Dabigatran Reversal by Idarucizumab in Nonclinical Studies and Predictions of Human Response

摘要

Dabigatran is a competitive direct thrombin inhibitor, a potent anticoagulant that is the active principle of the pro-drug, dabigatran etexilate. Idarucizumab, a humanized antibody fragment (Fab) is being developed as a specific reversal agent that binds to dabigatran and reverses its anticoagulant effects. This treatment will be made available for physicians to use in the case of traumatic injury or other instances when rapid reversal of dabigatran is desired (i.e. prior to emergency surgical procedure).