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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 for the treatment of Periodic Fever Syndromes (Cryopyrin-Associated Periodic Syndromes, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, Familial Mediterranean Fever), and active Still’s disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA).

Development timeline for Ilaris

Jun 16, 2020Approval Ilaris (canakinumab) Receives FDA Approval for New Indication to Treat Adult-Onset Still’s Disease (AOSD)
Sep 23, 2016Approval FDA Approves Expanded Indications for Ilaris (canakinumab) for Three Rare Periodic Fever Syndromes
May 10, 2013Approval Ilaris Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis
Aug 29, 2011FDA Requests Additional Clinical Data on Novartis Drug ACZ885 for the Treatment of Gouty Arthritis
Jun 22, 2011FDA Panel Endorses Efficacy but Not Safety of Novartis Drug ACZ885 for Gouty Arthritis; Did Not Support Approval in Proposed Indication
Jun 18, 2009Approval New Biological Therapy Ilaris Approved In US To Treat Children And Adults With CAPS, A Serious Life-Long Auto-Inflammatory Disease

Further information

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