Novartis announces NEJM publication of landmark PARADIGMS study demonstrating significant benefit of Gilenya in children and adolescents with MS

Treatment with Gilenya (fingolimod) substantially reduced the debilitating impact of MS, with significant decreases in key measures of disease activity vs. interferon beta-1a MS severely affects the everyday lives of children and adolescents with the disease and carries a significant impact throughout their lifetime Gilenya, a leading oral therapy for relapsing MS, is the only treatment approved by the US FDA for patients from 10 years of age through to adulthood  The digital press release with multimedia content can be accessed here: Basel, September 12, 2018 - Novartis today announced that The New England Journal of Medicine (NEJM) has published full results from the landmark Phase III Gilenya (fingolimod) PARADIGMS study, the first-ever controlled, randomized study specifically designed for children and adolescents (aged 10 to 17) with relapsing forms of MS (RMS). Children and adolescents with MS experience more frequent and often more severe relapses than those seen in adults with MS. The negative effect of relapses on movement, memory and thinking prevents patients from enjoying their childhood and adolescent years to the full, often leaving them feeling isolated and anxious. PARADIGMS met the primary endpoint of significantly reducing the rate of relapses when compared to interferon beta-1a intramuscular injections over a period of up to two years. The study also met several secondary clinical and imaging endpoints.