CINRYZE (C1 esterase inhibitor [human]), antifibrinolytic

RARE DISEASE - Paediatrics
Opinions on drugs - Posted on Mar 29 2018

Reason for request

Extension of indication

Substantial clinical benefit in the treatment of angioedema attacks and in their short- and long-term prevention, but no clinical benefit demonstrated in children in the treatment of this disease

 

  • CINRYZE has Marketing Authorisation in children aged 2 years and older in the treatment and pre-procedure prevention of angioedema attacks and for routine prevention of angioedema attacks in children aged 6 years and older.
  • Efficacy in paediatrics has been demonstrated with a low level of evidence, because it is based on post-hoc analyses in sub-groups or in non-comparative studies.
  • There is no data demonstrative of the impact of CINRYZE on quality of life of children or on the organisation of care.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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