Ilaris® (canakinumab)

BL 125319

Ilaris® (canakinumab)

BL 125319

U.S. License Holder:

Novartis Pharms.

Date of License:

June-17-2009

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

ILARIS (canakinumab) is an interleukin-1 beta blocker 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 Autoinflammatory Syndrome (FCAS); 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; and

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 aged 2 years 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.

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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