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FDA Approves Gilenya for MS in Children ≥10 Years

FDA Web site; 2018 May 11

The US Food and Drug Administration (FDA) recently approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents aged ≥10 years. This is the first FDA approval of a drug to treat MS in pediatric patients. Gilenya was first approved by the FDA in 2010 to treat adults with relapsing MS. The FDA granted the approval of Gilenya to Novartis, which is headquartered in Basel, Switzerland.

Most people with MS experience their first symptoms, such as vision problems or muscle weakness, between the ages of 20 to 40. 2-5% of people with MS have symptom onset <18 years and estimates suggest that 8,000 to 10,000 children and adolescents in the US have MS.

Indications: Gilenya is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS) in patients ≥10 years.

Dosage/administration: Recommended dosage for adults and pediatric patients (≥10 years) weighing >40 kg: 0.5 mg orally once-daily, with or without food. Recommended dosage for pediatric patients (≥10 years) weighing ≤40 kg: 0.25 mg orally once-daily, with or without food. Additional information:

Adverse reactions: Most common adverse reactions (incidence ≥10% and >placebo): headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.


FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients. FDA Web site. May 11, 2018. Accessed May 18, 2018.

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