Swiss pharma giant Novartis (NOVN: VX) has announced positive top-line results from a Phase III study investigating the safety and efficacy of oral once-daily Gilenya (fingolimod) in children and adolescents with multiple sclerosis (MS).
Data from the PARADIGMS study, the first ever randomized, controlled Phase III trial of a disease-modifying therapy in pediatric MS, shows a significant and clinically-meaningful reduction in the number of relapses in this patient population over a period of up to two years, compared to interferon beta-1a intramuscular injections.
The safety profile of fingolimod was consistent with that seen in other trials, with overall more adverse events reported in the group taking interferon beta-1a, a drug marketed by US biotech Biogen (Nasdaq: BIIB) under the brand name Avonex.
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