A treatment for relapsing multiple sclerosis (Gilenya — fingolimod) has been approved for use in children and adolescents aged 10 years and older by the US Food and Drug Administration (FDA).
Hope for MS
“For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis,” said Dr Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can have a profound impact on a child’s life. This approval represents an important and needed advance in the care of paediatric patients with multiple sclerosis.”
Gilenya originally received FDA approval in 2010 to treat adults with relapsing multiple sclerosis (MS). This latest extension to its approval has been based on the results of a clinical trial evaluating the effectiveness of the drug in paediatric patients. The trial included 214 evaluated patients aged between 10 and 17 years old and compared treatment of Gilenya with that of another MS drug — interferon beta-1a. Most patients receiving Gilenya (86%) remained relapse-free after 24 months of treatment, which compared with 46% of those receiving interferon beta-1a.
The FDA granted the approval of Gilenya to Novartis.