PRAXBIND (idarucizumab), antidote for dabigatran

ANTIDOTE - New medicinal product
Opinions on drugs - Posted on Oct 12 2016

Reason for request


No clinical benefit demonstrated when compared with current treatment

  • PRAXBIND is a neutralising agent specific to the anticoagulant effect of dabigatran (PRADAXA).
  • It is a humanized monoclonal antibody fragment that has Marketing Authorisation in adults treated with dabigatran etexilate when a rapid neutralisation of its anticoagulant effects is required due to a surgical emergency or urgent procedures, or in case of uncontrolled or life-threatening bleedings.
  • From the available clinical data it is not possible to estimate the impact of PRAXBIND in terms of morbidity and mortality compared to current symptomatic treatments.

Clinical Benefit



Clinical Added Value

no clinical added value


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