Canakinumab

Canakinumab (Ilaris, Novartis) is a fully human IgG1κ monoclonal antibody that neutralizes interleukin-1β. The FDA approved it in 2009 for cryopyrin-associated periodic syndromes (CAPS) and later for other autoinflammatory diseases (TRAPS, HIDS/MKD, FMF, Still's disease, sJIA); the EMA gave a parallel centralized authorization. In CANTOS, 150 mg subcutaneously every 3 months reduced the rate of recurrent major adverse cardiovascular events by ~15% in post-MI patients with hsCRP ≥2 mg/L, independent of LDL-cholesterol lowering, and an exploratory analysis suggested lower lung-cancer incidence and mortality. Canakinumab is not labeled for atherosclerosis or cancer in 2026, and high price plus increased serious-infection risk have limited cardiovascular adoption. After the FDA declined an atherosclerosis indication in 2018, Novartis announced it would not pursue further CV-indication filings for canakinumab.