Novartis: PARADIGMS Data Show 82% Lower Relapse Rate With Gilenya In MS

(RTTNews) - Novartis (NVS) reported full results from the positive Phase III PARADIGMS study, investigating the safety and efficacy of Gilenya (fingolimod) vs. interferon beta-1a, in children and adolescents (ages 10 to 17) with multiple sclerosis. The company said the treatment with oral Gilenya resulted in an 82% reduction in annualized relapse rate over a period of up to two years, compared to interferon beta-1a intramuscular injections. PARADIGMS data also showed that patients treated with Gilenya had significantly fewer new brain lesions vs. those on interferon beta-1a.

The safety profile of Gilenya was overall consistent with that seen in previous clinical trials, with more adverse events reported in the interferon group.

Gilenya is not currently approved for the treatment of pediatric multiple sclerosis. The company is working on submission with health authorities worldwide. The Phase III PARADIGMS study was conducted in 87 sites over 25 countries, and was designed in partnership with the US FDA, the European Medicines Agency and the International Pediatric Multiple Sclerosis Study Group.