Gilenya licence extended for children and teenagers


29 November 2018

The European Commission has approved the extension of the licence for Gilenya (fingolimod) to include treatment of children and adolescents 10 years or older with relapsing remitting MS.  

The decision confirms the recommendation made by the European Medicines Agency (EMA) based on results from the PARADIGMS phase III clinical trial.  In this study, 215 participants with relapsing remitting MS aged 10-17 years, took either Gilenya or Avonex (interferon beta 1a) for up to two years.  Gilenya reduced the relapse rate by 82% compared to Avonex.  There were also significantly fewer new lesions seen on MRI scans of those taking Gilenya.  Side effects were slightly more frequent in the Avonex group (95.3%) than the Gilenya group (88.8%), but in the Gilenya group the rate of serious side effects was higher – 6.5% versus 16.8%, respectively.

Gilenya is the first disease modifying drug (DMD) licenced for treatment of young people, although in the UK the full range of DMDs can be prescribed as appropriate.  In 2015, the Association of British Neurologists published guidelines for the prescribing of DMDs. They recommended that young people aged between 16 and 18 are treated according to their guidelines and that children under 16 should be assessed and treated in specialist clinics, preferably under a combined team that includes adult and paediatric neurologists with a specialist interest in MS.

Increasing numbers of young people are being affected by MS – either because they have MS themselves or because a family member has been diagnosed.  Getting your head around MS can be hard enough when you’re an adult. But for young people it can be devastating, so good quality information is vital.  To help young people get to grips with MS, the MS Trust has launched a new YouTube channel called MSTV.  The channel features a range of different videos about MS, and stars young people who are affected by MS in some way. 

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