Reason for request

Renewal of inclusion

Minor clinical added value in the management of growth delays related to a severe primary IGF-1 deficiency

 

  • INCRELEX (recombinant human IGF-1) has had marketing authorisation since 2007 in the long-term treatment of growth delays in children and adolescents aged 2 to 18 years with a severe primary IGF-1 deficiency.
  • Its effect on growth is variable and is difficult to assess, given the low amount of data available and the wide variability of effect from one patient to another.
  • It is the only treatment available for the management of severe primary IGF-1 deficiency, so the benefit must be assessed with regard to the frequency of its short-term adverse effects, in particular hypoglycaemia.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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