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FDA Approves First Treatment for Pediatric MS

On May 11, 2018, the FDA approved Gilenya (fingolimod) for an expanded indication to treat relapsing MS in children ten years of age or older living with the condition. This marks the first FDA approval for a drug to treat pediatric MS.1

How many children have MS?

Of the estimated 400,000 people in the US living with MS, approximately 2-3% of those are pediatric patients. However, according to the National MS Society, 2-5% of people living with MS experience their first symptoms prior to the age of 18.2 The symptoms of MS can mimic those of many other conditions, so an MS diagnosis is typically not considered for children due to its infrequency.

Clinical trial

A clinical trial tested the efficacy of Gilenya in pediatric patients aged 10-17. Researchers compared Gilenya to another MS treatment in 214 patients. The side effects experienced by pediatric patients while taking Gilenya were similar to those experienced by adults receiving the treatment.1 After two years, 86% of the patients receiving Gilenya were relapse-free compared to 46% of those receiving the comparative treatment.1 Children with MS experience 2-3 times more frequent relapses and reach disability milestones at an earlier age than adults with MS.3,4 The availability of a disease-modifying therapy for pediatric patients is an important advancement and uplifting news for patients and their families.

  1. FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients. US Food and Drug Administration. Accessed May 13, 2018.
  2. Pediatric MS. National Multiple Sclerosis Society. Accessed May 13, 2018.
  3. Gorman MP, Healy BC, Polgar-Turcsanyi M, Chitnis T. Increased Relapse Rate in Pediatric-Onset Compared With Adult-Onset Multiple Sclerosis. Arch Neurol. 2009;66(1):54–59. doi:10.1001/archneurol.2008.505
  4. Harding KE, Liang K, Cossburn MD, et al. Long-term outcome of paediatric-onset multiple sclerosis: a population-based study. J Neurol Neurosurg Psychiatry Published Online First: 15 November 2012. doi:10.1136/jnnp-2012-303996