Ilaris

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Questions & Answers

On 23 June 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ilaris. The marketing authorisation holder for this medicinal product is Novartis Europharm Ltd.

The CHMP adopted an extension to an existing indication as follows*:

Systemic Juvenile Idiopathic ArthritisStill’s Disease

Ilaris is indicated for the treatment of active Still’s disease including Adult-Onset Still’s Disease (AOSD) andactive Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate.

For information, the full indications for Ilaris will be as follows:

'Cryopyrin-Associated Periodic Syndromes

Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:

  • Muckle-Wells Syndrome (MWS),
  • Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA),
  • Severe forms of Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.

Still’s Disease

Ilaris is indicated for the treatment of active Still’s disease including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate.

Gouty arthritis

Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (see section 5.1).'

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


*New text in bold, removed text as strikethrough.

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Ilaris (English only) 2016-06-24  

Key facts

Product details for Ilaris
NameIlaris
INN or common name

canakinumab

Therapeutic area Cryopyrin-associated Periodic SyndromesArthritis, Juvenile RheumatoidArthritis, Gouty
Active substance

canakinumab

Date opinion adopted23/06/2016
Company name

Novartis Europharm Ltd

StatusPositive
Application typePost authorisation