Two CHMP positives for Novartis

There was a flow of positive news from the European Medicines Agency on Friday (July 26) for Swiss drug major Novartis (NOVN: VX), when the EMA’s Committee for Medicinal Products for Human Use (CHMP) reported decisions made at its July meetings, recommending approval of the firm’s Ilaris (canakinumab) as well as its once-daily Ultibro Breezhaler (indacaterol 85mcg/glycopyrronium 43mcg delivered dose).

Ilaris was backed in the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older. SJIA is a rare and disabling form of childhood arthritis with limited treatment options. The US Food and Drug Administration approved this indication earlier this year (The Pharma Letter May 10), and the drug is already approved for other arthritis conditions in the USA and Europe, as well as other countries.

This opinion 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 as compared to those in the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75).