PRAXBIND (idarucizumab), dabigatran neutralising agent

High clinical benefit for emergency neutralisation of the anticoagulant effect of dabigatran and minor clinical improvement, only in cases where no therapeutic alternative is available

• PRAXBIND is a specific neutralising agent of the anticoagulant effect of dabigatran (PRADAXA), a direct thrombin inhibitor. PRAXBIND binds with dabigatran with a very strong affinity, approximately 300 times stronger than that of dabigatran for thrombin. It specifically neutralises the anticoagulant effect of dabigatran without interfering with other oral anticoagulants.

• It has MA for adults treated with dabigatran when rapid neutralisation of its anticoagulant effects is required for a surgical emergency or urgent procedures or in case of uncontrolled or life-threatening bleeding.

• The data available do not allow an estimation of the direct impact of PRAXBIND in terms of morbidity and mortality compared to the conventional treatment.