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EMA approves Gilenya for childhood MS

The European Medicines Agency (EMA) has approved Gilenya (fingolimod) for the treatment of young people living with relapsing MS. Gilenya is the first and only DMT licensed for this age group.

MS in young people

Typically, children and young people with MS relapse two-to-three times more frequently than adults, and have more severe symptoms. MS has been shown to affect children and young people’s performance at school, family relationships, and daily life.

Promising results

A Phase 3 trial showed that treatment with Gilenya could significantly improve symptoms, reducing relapse rates by 82% compared to the current standard of care. The results were published in the New England Journal of Medicine (NEJM) in September this year.

Our Director of External Affairs, Genevieve Edwards, said: “MS is hard enough, but for a child or young person affected the challenges can become even more severe. Trying to navigate growing up, school, friendships, and family life on top of painful and exhausting MS symptoms is more than any child should have to cope with. Today marks an important milestone in vital efforts to ensure that all children with MS have effective treatment options, so they can focus on realising their potential rather than managing their MS.

What happens next?

Gilenya will be appraised by relevant health bodies to decide whether it should be available on the NHS. No dates have been set for this but we will be working to ensure it happens as soon as possible.

Is Gilenya safe?

The safety of Gilenya was tested as part of a clinical trial, on which the EMA based its approval. But the USA Food and Drug Administration issued a separate warning on 21 November 2018, stating that when Gilenya is stopped, in rare cases MS can become much worse than before the medicine was started or while it was being taken.

We advise children and parents to discuss this risk with their neurologist when considering Gilenya as a treatment option.

Read more about childhood MS

Read more about Gilenya