Kineret FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 21, 2023.

FDA Approved: Yes (First approved November 14, 2001)
Brand name: Kineret
Generic name: anakinra
Dosage form: Injection
Company: Swedish Orphan Biovitrum AB
Treatment for: Rheumatoid Arthritis, Cryopyrin-Associated Periodic Syndromes, Interleukin-1 Receptor Antagonist Deficiency, COVID-19

Kineret (anakinra) is an interleukin-1 receptor antagonist used for the treatment of rheumatoid arthritis, cryopyrin-associated periodic syndromes, deficiency of interleukin-1 receptor antagonist, and COVID-19 related pneumonia.

• Kineret is indicated for:
  - 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).
  - Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID), the most severe form of cryopyrin associated periodic syndromes (CAPS).
  - Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA).
• The FDA has issued an Emergency Use Authorization (EUA) for the emergency use of Kineret for the treatment of COVID-19 in hospitalized adults with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). Kineret is not FDA approved for this use.

Development timeline for Kineret

Further information

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