Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial

In a proof-of-concept study in healthy volunteers, idarucizumab (monoclonal antibody fragment that binds dabigatran) was found to immediately and completely reverse dabigatran-induced anticoagulation in a dose-dependent manner.

Idarucizumab is a fully humanised monoclonal antibody fragment which has a highly specific binding affinity with dabigatran therefore reversing any anticoagulant activity of dabigatran and its metabolites. It is intended to be used as first line therapy for the reversal of anticoagulation due to treatment with dabigatran, and if licensed will offer a novel treatment option for patients on dabigatran therapy experiencing life-threatening or uncontrolled haemorrhage, or in need of emergency surgery/procedures, who currently have no specific targeted treatment options available.

 

 

Boehringer Ingelheim filed idarucizumab for approval in the EU in March 2015. The submission includes first interim data from an ongoing Phase III study (RE-VERSE ADTM), which is assessing idarucizumab in patients treated with dabigatran who are in need of emergency intervention, or experience an uncontrolled or life-threatening bleeding event. This trial is expected to complete in July 2017.