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Kineret (anakinra)

Kineret (anakinra). The FDA Perspective. CBER Review Team. Raymond Donnelly, Ph.D.: Product (CMC) Jeffrey Siegel, M.D.: Clinical George Mills, M.D.: Clinical (imaging) Debra Bower: Bio-Research Monitoring BoGuang Zhen, Ph.D.: Biostatistics Anne Pilaro, Ph.D.: Preclinical pharm/tox

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Kineret (anakinra)

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  1. Kineret (anakinra) The FDA Perspective

  2. CBER Review Team • Raymond Donnelly, Ph.D.: Product (CMC) • Jeffrey Siegel, M.D.: Clinical • George Mills, M.D.: Clinical (imaging) • Debra Bower: Bio-Research Monitoring • BoGuang Zhen, Ph.D.: Biostatistics • Anne Pilaro, Ph.D.: Preclinical pharm/tox • Laurie Paserchia, M.D.: Clinical pharmacol. • Reginald Neal: Compliance • Victoria Tyson-Medlock: Regulatory

  3. BLA# 99-1490 (STN: 103950) • Dec. 28, 1999: Application received • Assigned a standard 10-month review • April 2000: Pre-license inspection • Nov. 17, 2000: Complete Review letter sent • March 2, 2001: Response from Amgen • Classifed as a class-2 resubmission

  4. Kineret (anakinra) • Recombinant human IL-1 receptor antagonist • Expressed in E. coli • Amino acid sequence is identical to native human IL-1ra except for the addition of an N-terminal methionine residue • Molecular weight = 17.3 kDa

  5. Kineret (anakinra) • Anakinra is purified through a series of chromatography steps • The purified bulk drug substance (BDS) is analyzed for identity, purity and potency • The purified BDS is formulated and sterile filtered • The finished drug product is supplied in prefilled syringes as a sterile, clear, colorless, preservative-free liquid

  6. Kineret (anakinra) • Inhibits the action of IL-1 by competitively blocking the binding of IL-1 to IL-1 receptors on IL-1 responsive target cells • PK studies showed that the terminal half-life of anakinra following SC administration ranges from 3 to 6 hours • No evidence of drug accumulation in RA patients after daily dosing for up to 24 weeks

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