European Commission approves Gilenya to treat children and adolescents with r/r multiple sclerosis. - Novartis

Novartis announced that the European Commission (EC) has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS). The European market authorization makes Gilenya the first and only oral disease-modifying treatment for children and adolescents based on clinical Phase III data. This young population living with MS have a critical need for an effective treatment option, as they experience two-to-three times as many relapses as adults, often leading to a more severe prognosis and earlier irreversible disability compared to adult-onset MS.

The EC's approval is based on the PARADIGMS trial, a landmark Phase III clinical study in MS, specifically designed for children and adolescents 10 to 17 years old. Results from the double-blind, randomized, multi-center study of Gilenya vs. interferon beta-1a show that Gilenya significantly reduced the annualized relapse rates by 82% (compared to interferon beta-1a, p<0.001) and 85.7 of patients treated with gilenya were relapse-free at up to 24 months versus 38.8 of patients treated with interferon beta-1a p><0.001). patients treated with gilenya also showed a 77 risk reduction of disability progression relative to patients treated with interferon beta-1a. furthermore it also significantly reduced the number of new or newly enlarged t2 lesions up to 24 months by 53 compared to interferon beta-1a p><0.001) and the annualized rate of brain volume loss brain shrinkage by 40 compared to interferon beta-1a p="0.014)." the full paradigms data were published in the new england journal of medicine in september 2018.>