FDA Approves First Treatment for Pediatric MS
On May 11, 2018, Novartis announced that Gilenya® (fingolimod) was approved by the United States Food and Drug Administration (FDA) for the treatment of children and adolescents, ages 10 through 17, with relapsing multiple sclerosis (MS). This is the first disease-modifying therapy (DMT) to be approved for this form of the disease in this age group.
Known as “pediatric MS,” nearly all of those diagnosed have the relapsing form of the disease. Children also experience approximately two-to-three times as many relapses as an individual with adult-onset MS. A clinical trial comparing Gilenya to Avonex® (interferon beta-1a) in children and adolescents found that those treated with Gilenya saw an 82-percent reduction in their annualized relapse rate over a period of up to two years.
Please see MSAA's online news article, "FDA Approves Gilenya® for Pediatric MS,"for more information.
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