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Results Published of Clinical Trial that Tested Gilenya (fingolimod) for Pediatric MS

September 13, 2018

- Trial led to FDA-approved expansion of the use of Gilenya to include children 10 years or older with relapsing MS
Results from a phase 3 clinical trial comparing Gilenya® (fingolimod, Novartis AG) and Avonex® (interferon beta-1a, Biogen) in children and teens with relapsing MS have been published in the September 13, 2018 issue of The New England Journal of Medicine. Gilenya reduced relapse rates by 82% over two years, compared to treatment with Avonex, and significantly reduced the rate of new or enlarging MS lesions shown on MRI. The side effects during the trial were similar to what have been seen in the adult population. Information on potential adverse events is outlined in the prescribing information and Medication Guide for patients and families.
The results of the published study led to the May 2018 approval by the U.S. Food and Drug Administration that expanded the use of Gilenya to include the treatment of children and adolescents 10 years of age or older with relapsing MS. This was the first disease-modifying therapy specifically approved for pediatric MS. The National MS Society’s early and fundamental work creating consistency around the diagnosis and care of children with MS helped lay the groundwork for this major milestone.
Read announcement about FDA’s approval of Gilenya for children with relapsing MS
Read the scientific abstract of the published paper in The New England Journal of Medicine

About Multiple Sclerosis

Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.

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The National MS Society, founded in 1946, is the global leader of a growing movement dedicated to creating a world free of MS. The Society funds cutting-edge research for a cure, drives change through advocacy and provides programs and services to help people affected by MS live their best lives. Connect to learn more and get involved:, Facebook, X, formerly known as Twitter, Instagram, YouTube or 1-800-344-4867.


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