The fully humanised antibody fragment (FAB) idarucizumab has been designated “breakthrough therapy” by the FDA, which should help to expedite its development.

Last year a phase 1/2 study showed that idarucizumab produces immediate, complete and sustained reversal of anticoagulation induced by dabigatran in healthy human volunteers.

A phase 3 study (RE-VERSE AD) is now taking place in patients on dabigatran who develop uncontrolled bleeding or who require emergency surgery. Unlike warfarin, at present there are no approved agents for reversing the anticoagulant effects of the newer oral anticoagulants like dabigatran and rivaroxaban.