Kineret anakinra

Drug Class

Interleukin-1 (IL-1) receptor antagonist

Mechanism

Anakinra blocks the biologic activity of IL-1 alpha and IL-1 beta by competitively inhibiting their binding to the interleukin-1 type I receptor.

Approved Indication

Treatment of rheumatoid arthritis (RA), Cryopyrin-Associated Periodic Syndromes (CAPS), Deficiency of Interleukin-1 Receptor Antagonist (DIRA), and Still's disease; approved by NMPA for Familial Mediterranean Fever (FMF) and Still's disease.

What This Means For Patients

Kineret (anakinra) is a recombinant interleukin-1 receptor antagonist used to treat rheumatoid arthritis, Still's disease, and rare autoinflammatory periodic fever syndromes like CAPS and FMF. It helps reduce inflammation caused by excess interleukin-1. It is approved in mainland China and also accessible in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2001) — label
• EMA — approved (2002) — source
• NMPA — approved (2023) — source

Pivotal Clinical Evidence

• NCT00069329 — Goldbach-Mansky et al., N Engl J Med 2006 (NCT00069329) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5175lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/kineret
• https://doi.org/10.1056/NEJMoa055137