Ilaris FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
FDA Approved: Yes (First approved June 17, 2009)
Brand name: Ilaris
Generic name: canakinumab
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: Cryopyrin-Associated Periodic Syndromes, Juvenile Idiopathic Arthritis, Familial Cold Autoinflammatory Syndrome, Muckle Wells Syndrome, Familial Mediterranean Fever, Still's Disease, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome
Ilaris (canakinumab) is a human anti-interleukin-1β monoclonal antibody used for the treatment of Periodic Fever Syndromes, active Still’s disease, and gout flares.
Ilaris is indicated for the treatment of:
- Periodic Fever Syndromes
- Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).
- Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients.
- Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients.
- Familial Mediterranean Fever (FMF) in adult and pediatric patients. - Active Still’s Disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older.
- Gout flares in adults 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.
Development timeline for Ilaris
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
