Canakinumab, a fully-human mAb against IL-1beta for the potential treatment of inflammatory disorders.

Novartis AG is developing canakinumab, an intravenously or subcutaneously infused, fully human mAb that neutralizes the bioactivity of human IL-1beta, which is involved in several inflammatory disorders. Canakinumab has promising clinical safety and pharmacokinetic properties, and demonstrated potential for the treatment of cryopyrin-associated periodic syndromes (CAPS) and possibly for other complex inflammatory diseases, such as rheumatoid arthritis, systemic-onset juvenile idiopathic arthritis (SoJIA), COPD disease and ocular diseases. Currently in phase III clinical development, canakinumab was recently granted EU and US Orphan Drug status for SoJIA and CAPS. Early clinical trials have established the administration of canakinumab every 2 weeks to be safe and effective, offering a considerable advantage over the existing treatment with the human IL-1 receptor antagonist anakinra, which must be injected daily and which is often poorly tolerated by patients. The availability of more than one IL-1 targeting biological agent is undoubtedly advantageous, not only for patients and clinicians, but also for the elucidation of disease mechanisms.