European regulators have approved Novartis’ Gilenya for the treatment of children and adolescents from 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS).
This decision means that Gilenya (fingolimod), which is an immunosuppressant that works by keeping immune cells trapped in the lymph nodes so they can't reach the central nervous system, is the first and only licensed oral disease-modifying treatment for children and adolescents with the disease.
The approval was supported by the PARADIGMS Phase III study, which compared Gilenya with interferon beta-1a (the current injectable standard of care for this group), and demonstrated that it significantly delayed the time to first relapse and reduced relapse rates by 82%.
MS is currently the leading cause of non-traumatic neurological disability in young people in Europe, and it’s thought that around 3% to 5% of patients experience disease onset before they reach the age of 18.
Children and young people diagnosed with the condition typically have two to three times more frequent disease relapses than the adult population, often leading to a more severe prognosis and earlier irreversible disability compared to adult-onset MS.
“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,” said Mark Toms, chief scientific officer at Novartis Pharmaceuticals UK.