These data expand on existing observations in young, healthy volunteers by showing that idarucizumab (a humanized monoclonal antibody fragment) immediately reverses the anticoagulant effect of dabigatran in middle-aged, elderly and renally impaired volunteers.

Efficacy of idarucizumab in renally impaired subjects was observed, together with an increase in exposure and reduced clearance of idarucizumab in this group.

An ongoing phase III study, RE-VERSE AD™, is assessing the effect of idarucizumab 5 g on dabigatran-induced anticoagulation in emergency patients with uncontrolled bleeding or who require urgent surgery or procedures.