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Novartis announces EU approval of Gilenya® (fingolimod), the first licensed oral treatment for paediatric MS

·         Children and young people diagnosed with MS typically relapse two-to-three times more frequently than adults, causing increased symptom severity1


·         Paediatric MS has been shown to affect children and young people’s performance at school, family relationships and ability to participate in everyday routines2


·         Recently published data show treatment with Gilenya® (fingolimod) led to significant decrease in key measures of disease activity3


Frimley, November 29, 2018 Novartis today announced that the European Medicines Agency (EMA) 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 licensed oral disease-modifying treatment for children and adolescents.


MS is currently the leading cause of non-traumatic neurological disability in young people in Europe4, and it’s thought that approximately 3% to 5% of MS patients experience disease onset before they reach the age of 185. Children and young people diagnosed with the condition typically have two-to-three times more frequent disease relapses than the adult population1, often leading to a more severe prognosis and earlier irreversible disability compared to adult-onset MS1. Symptoms include impaired mobility, poor vision, unsteadiness, fatigue and dizziness6.


Approximately 30% of young people with MS experience severe cognitive impairment, which has been linked to lowered academic performance in school, and often impacts relationships with family and friends7,8. In addition, it is thought that half of children diagnosed as living with the condition will show signs of depression within two years of disease onset 9.


“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 paediatric MS can often leave them feeling isolated and anxious.” said Dr. Cheryl Hemingway, Consultant Paediatric Neurologist leading the Neuroinflammation Service at Great Ormond Street Hospital, London and 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.”


The application for license was supported by the PARADIGMS Phase III study, published in the New England Journal of Medicine (NEJM) in September 20183. The study compared Gilenya with interferon beta-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%3


“Our work to bring Gilenya to the paediatric MS population demonstrates Novartis’ commitment to reimagining care for all people living with neurological conditions, regardless of their age or severity of disease progression,” said Dr Mark Toms, Chief Scientific Officer at Novartis Pharmaceuticals UK. “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.”


Novartis is working closely with all stakeholders to ensure eligible children and young adults with MS in the UK can benefit from this treatment as quickly as possible. In the EU, Gilenya is approved for adult patients with highly-active relapsing-remitting MS (RRMS) defined as either high disease activity despite treatment with at least one DMT, or rapidly-evolving severe RRMS10.


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Last Updated: 04-Dec-2018