Gilenya® gains EMA approval for pediatric multiple sclerosis

Novartis (Frimley, UK) has announced that the EMA has approved Gilenya® (fingolimod) for the treatment of children and adolescents aged 10–17 with relapsing–remitting forms of multiple sclerosis (MS). This marketing authorization makes Gilenya the first and only licensed oral disease-modifying treatment for children and adolescents. Children and young people diagnosed with MS are reported to have two- to three-times more frequent disease relapses than the adult population, which often leads to a more severe prognosis and earlier irreversible disability compared with adult-onset MS. “Frequent relapses and symptoms can prevent children and young people from participating fully in normal day-to-day activities...