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