EU CHMP recommends change of approval of Ilaris (canakinumab) for Adult-Onset Still's Disease and Systemic Juvenile Idiopathic Arthritis- Novartis

The EU 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 (canakinumab), from Novartis. Ilaris is now 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.

Ilaris is also 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.