Gilenya® gains EMA approval for pediatric multiple sclerosis

Written by Sharon Salt, Editor

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 and education, and the unpredictable nature of pediatric MS can often leave them feeling isolated and anxious,” said Cheryl Hemingway, chief investigator for the PARADIGMS trial in the UK.

“We hope that the landmark milestone of the first approved oral therapy for children and young people heralds a new era of treatment for these patients,” she added.

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The application for the license was supported by the PARADIGMS Phase III study, which was published in the New England Journal of Medicine in September 2018. In the trial, researchers compared Gilenya with interferon β-1a (the current injectable standard of care for this group) and demonstrated that Gilenya significantly delayed the time to first relapse and reduced relapse rates by 82%.

Within the study, the authors stated that: “among pediatric patients with relapsing MS, fingolimod was associated with a lower rate of relapse and less accumulation of lesions on MRI over a 2-year period than interferon β-1a, but was associated with a higher rate of serious adverse events.”

“Our work to bring Gilenya to the pediatric MS population demonstrates Novartis’ commitment to reimagining care for all people living with neurological conditions, regardless of their age or severity of disease progression,” commented Mark Toms, Chief Scientific Officer at Novartis. “Our mission is to change the course of MS, and we are delighted that this approval brings us one step closer to building a better future for people living with the condition here in the UK.”

Currently in the EU, Gilenya is approved for adult patients with highly active relapsing–remitting MS, defined as either high disease activity despite treatment with at least one disease-modifying treatment, or rapidly evolving severe relapsing–remitting MS.

Sources: Chitnis T, Arnold DL, Banwell B et al. Trial of fingolimod versus interferon beta-1a in pediatric multiple sclerosis. N. Engl J. Med. doi:10.1056/NEJMoa1800149 (2018) (Epub ahead of print); Novartis. Novartis announces EU approval of Gilenya® (fingolimod), the first licensed oral treatment for paediatric MS. Press release: