PRAXBIND (idarucizumab), dabigatran neutralising agent

Opinions on drugs - Posted on Dec 18 2018

Reason for request

Re-assessment of the improvement in actual benefit

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.



Clinical Benefit



Clinical Added Value



no clinical added value

Therapeutic use