First Pediatric Multiple Sclerosis Drug Approved by FDA | FDA Press Release


The US FDA has approved fingolimod (Gilenya by Novartis) for the treatment of multiple sclerosis (MS) in children aged 10 years or older.

Key Points

  • Once-daily, taken orally
  • Inhibits lymphocyte migration to CNS (downregulates sphingosine receptor)
  • Approved since 2010 for relapsing MS in adults
  • Current first-line: Interferon beta/glatiramer acetate injections (off-label in pediatric MS)


  • PARADIGMS Trial: 214 patients 10-17y
  • PARADIGMS Trial: Fingolimod arm (86% relapse free), INF-beta arm (46% relapse free) after 2 years
  • Serious risks: bradycardia, infection, progressive multifocal leukoencephopathy, vision changes, posterior reversible encephalopathy, hepatotoxicity, respiratory difficulty, hypertension, skin malignancy



Source: Press Announcements > FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients