Neurology Central

Gilenya® gains EMA approval for pediatric multiple sclerosis

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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.

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