Canakinumab
Canakinumab (Ilaris, from Novartis) is a fully human antibody. It neutralizes the inflammatory signal interleukin-1β (IL-1β) in your body. The FDA approved it in 2009 for a rare genetic syndrome (CAPS). It was later approved for other autoinflammatory diseases. These include TRAPS, HIDS/MKD, FMF, Still's disease, and sJIA. The EMA gave a parallel approval. Its big cardiovascular moment came in the CANTOS trial. The dose was 150 mg under the skin every 3 months. It cut recurrent major cardiovascular events by about 15%. That was in post-heart-attack patients with high hsCRP (≥2 mg/L). And it worked independent of LDL lowering. An exploratory analysis even hinted at lower lung-cancer rates. But canakinumab is not labeled for atherosclerosis or cancer as of 2026. Its high price, plus a raised risk of serious infection, have limited cardiovascular use. The FDA declined an atherosclerosis indication in 2018. After that, Novartis said it would stop pursuing further cardiovascular filings.
Last reviewed:
This definition is educational and is not medical advice, a diagnosis, or treatment. Talk to a doctor about any health decisions. Read our full medical disclaimer
Sources
- Ridker PM, Everett BM, Thuren T, et al.. (2017). Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease. *New England Journal of Medicine*doi:10.1056/NEJMoa1707914
- Ridker PM, MacFadyen JG, Thuren T, et al.. (2017). Effect of interleukin-1β inhibition with canakinumab on incident lung cancer in patients with atherosclerosis: exploratory results from a randomised, double-blind, placebo-controlled trial. *The Lancet*doi:10.1016/S0140-6736(17)32247-X
- Novartis Pharmaceuticals / U.S. Food and Drug Administration. (2009). Ilaris (canakinumab) FDA Prescribing Information