Positive Results Announced from a Phase III Trial of Fingolimod in Children and Adolescents with MS
September 6, 2017
A study in children and adolescents with MS showed that treatment with oral fingolimod (Gilenya®, Novartis) significantly reduced the number of relapses over a period of up to two years, compared to treatment with interferon beta-1a, according to a press release from Novartis. The full results will be presented at the ECTRIMS-ACTRIMS meeting in October in Paris, France. Fingolimod is not currently approved for the treatment of pediatric MS. Novartis plans to analyze these data and present the results to regulatory authorities.
Although MS occurs most commonly in adults, it is also diagnosed in children and adolescents. This study, also known as the PARADIGMS study, is the first completed clinical trial to formally evaluate the safety or effectiveness of a disease-modifying therapy in pediatric MS. The study compared Fingolimod to another therapy, interferon beta-1a (Avonex®, Biogen), so that all participants were on active therapy during the trial.
Fingolimod was approved by the U.S. Food and Drug Administration in 2010 for adults with relapsing forms of MS. Fingolimod is called a sphingosine 1-phosphate receptor modulator, which is thought to act by retaining certain white blood cells in the lymph nodes, preventing them from crossing the blood-brain barrier into the central nervous system. Preventing the entry of these cells reduces inflammatory damage to nerve cells.