FDA Expands MS Drug Indication

The US Food and Drug Administration (FDA) has approved Gilenya (fingolimod) for the treatment of relapsing multiple sclerosis (MS) in children and adolescents aged 10 years and older.

First approved to treat adults with relapsing MS in 2010, GIlenya is now the first FDA-approved drug for the treatment of pediatric MS.

The approval was granted following a clinical trial that compared the effectiveness of Gilenya with interferon beta-1a. A total of 214 patients aged 10 to 17 years were evaluated.

Results of the trial showed that 86% of Gilenya-treated patients remained relapse-free after 24 months of treatment compared with 46% of those who were treated interferon beta-1a.

Common side effects of Gilenya reported among pediatric trial participants were similar to those observed among adults and included headache, liver enzyme elevation, diarrhea, cough, flu, sinusitis, back pain, abdominal pain, and pain in extremities.

—Christina Vogt

Reference:

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients [press release]. US Food and Drug Administration. May 11, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607501.htm?utm_campaign=05112018_FDA approves Galenya&utm_medium=email&utm_source=Eloqua Accessed on May 14, 2018.