Kineret® (anakinra)

BL 103950

Kineret® (anakinra)

BL 103950

U.S. License Holder:

Biovitrum AB

Date of License:

November-14-2001

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

KINERET (anakinra) is an interleukin-1 receptor antagonist indicated for:

Rheumatoid Arthritis (RA): Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs);

Cryopyrin-Associated Periodic Syndromes (CAPS): Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID);

Deficiency of Interleukin-1 Receptor Antagonist (DIRA): Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA).

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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