The US Food and Drug Administration (FDA) has approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents aged 10 years and older.
This is the first FDA approval of a drug to treat MS in paediatric patients.
‘For the first time, we have an FDA-approved treatment specifically for children and adolescents with MS,’ explained Billy Dunn, MD, Director of the Division of Neurology Products in the FDA’s Centre for Drug Evaluation and Research.
‘MS 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 MS.’
Gilenya was first approved by the FDA in 2010 to treat adults with relapsing MS.
The clinical trial evaluating the effectiveness of Gilenya in treating paediatric patients with MS included 214 evaluated patients aged 10 to 17 and compared Gilenya to another MS drug, interferon beta-1a. In the study, 86 per cent of patients receiving Gilenya remained relapse-free after 24 months of treatment, compared to 46 per cent of those receiving interferon beta-1a.