EU approval for Ilaris in active systemic juvenile idiopathic arthritis

Following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human USE (CHMP) for Swiss drug major Novartis (NOVN:VX) and USA-based Regeneron Pharmaceuticals’ (Nasdaq: REGN) Ilaris (canakinumab; The Pharma Letter July 29), the European Commission has approved the use of the drug in the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older, who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.

This approval was based on two Phase III trials in SJIA patients, aged two-19, which showed significant improvement in the majority of Ilaris-treated patients. Study 1 showed that 84% of patients treated with one subcutaneous dose of Ilaris achieved the primary endpoint of the adapted pediatric American College of Rheumatology 30 (ACR30), compared to 10% achievement of ACR30 for placebo at Day 15. In the open-label part of Study 2, 92 of 128 patients attempted "corticosteroid tapering."

Of those 92 patients, 62% were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids. In the controlled portion of Study 2, there was a 64% relative reduction in the risk of flare for patients in the Ilaris group compared to those in the placebo cohort (hazard ratio of 0.36; 95% CI: 0.17 to 0.75). Data from a pooled efficacy analysis showed that after 12 weeks of Ilaris treatment 61% of patients reached an adapted pediatric ACR70 and 28% of patients had inactive disease.