PRAXBIND (idarucizumab), antidote for dabigatran

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

Reason for request

Inclusion

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

Substantial

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Clinical Added Value

no clinical added value

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