ILARIS canakinumab

Drug Class

Interleukin-1 beta (IL-1β) blocker

Mechanism

Canakinumab binds to human IL-1β with high affinity, neutralizing its activity and preventing its interaction with IL-1 receptors to resolve inflammation.

Approved Indication

Treatment of Periodic Fever Syndromes, including Cryopyrin-Associated Periodic Syndromes (CAPS); Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS); Still's Disease (AOSD and SJIA); and gout flares.

What This Means For Patients

Ilaris (canakinumab) is a targeted monoclonal antibody that blocks interleukin-1 beta (IL-1β) to treat rare autoinflammatory diseases and severe gout flares. It reduces the body's inflammatory response. While not approved by the NMPA in mainland China, it is available for eligible patients in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2009) — label
• EMA — approved (2009) — source

Pivotal Clinical Evidence

• CACZ885D2304 — Lachmann et al., N Engl J Med 2009 (NCT00465985) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125287s063lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/ilaris
• https://doi.org/10.1056/NEJMoa0810787