Boehringer Ingelheim has filed idarucizumab for approval in the US, European Union and Canada for use in patients requiring an antidote to the bloodthinner Pradaxa.
The drug is a fully humanised antibody fragment designed specifically to reverse the anticoagulant effects of Pradaxa (dabigatran etexilate), and its submission marks a global first for an investigational specific reversal agent to a novel oral anticoagulant, BI said.
Idarucizumab picked up Breakthrough Designation in the US last year, after Phase I studies showed that the agent induced “immediate, complete and sustained reversal of dabigatran-induced anticoagulation in healthy humans”, according to the firm.
The submissions also include first interim data from the ongoing Phase III RE-VERSE ADTM study, assessing idarucizumab in patients treated with Pradaxa who are in need of emergency intervention, or experience an uncontrolled or life-threatening bleeding event.
