Novartis' Ilaris provides substantial symptom relief in 84% of patients with most serious form of childhood arthritis

Swiss drug major Novartis (NOVO: VX) announced positive results of the first pivotal Phase III trial of ACZ885 (canakinumab) in patients with systemic juvenile idiopathic arthritis (SJIA), a rare and serious childhood auto-inflammatory disease at the 2011 European Pediatric Rheumatology Congress in Bruges, Belgium, showing that all primary and secondary endpoints of the study were met.

Canakinumab, marketed under the trade name Ilaris, was approved in 2009 in the USA and European Union for the treatment of cryopyrin associated periodic syndrome (CAPS), but failed to gain Food and Drug Administration clearance for gouty arthritis, following a complete response letter from the agency last month (The Pharma Letter August 31). Novartis has previously said that the SJIA indication, together with gouty arthritis and CAPS, could push the drug’s sales over the $1 billion-a-year level in due course.

Most ACZ885 patients (83.7%) experienced at least a 30% improvement in symptoms versus 9.8% for placebo (p<0.0001) and a third of ACZ885 subjects (32.6%) achieved a 100% improvement vs 0% for placebo (p=0.0001). ACZ885 is an investigational, fully human monoclonal antibody that neutralizes interleukin-1 beta (IL-1 beta), which is a key driver of inflammation in SJIA.