ILARIS (canakinumab), interleukin 1 inhibitor

RARE DISEASE - New indication
Opinions on drugs - Posted on Mar 06 2018

Reason for request

Extension of indication

Minor improvement in the treatment of 3 inflammatory syndromes

 

  • ILARIS has Marketing Authorisation in the treatment of three forms of hereditary recurrent fevers in adults, adolescents and children aged 2 years and older:
    •  TNF-associated periodic syndrome (TRAPS),
    •  hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and
    •  familial Mediterranean fever (FMF).
  • Its superiority relative to placebo has been demonstrated in these 3 diseases in terms of resolution of the initial attack at 15 days and absence of new flare-up within 4 months after treatment. 
  • ILARIS has not shown to have a long-term effect in the prevention of secondary amyloidosis, a source of morbidity and mortality.

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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