(Reuters) - The U.S. Food and Drug Administration (FDA) on Friday expanded the use of Novartis AG’s relapsing multiple sclerosis (MS) drug Gilenya to treat children and adolescents.
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body and is among the most common causes of neurological disability in young adults.
Gilenya is the first FDA-approved drug to treat pediatric patients suffering from relapsing MS, the U.S. health regulator said.
In a clinical trial 86 percent of patients receiving Gilenya remained relapse-free after 24 months of treatment, compared to 46 percent of those who were administered another MS drug.
Gilenya was first approved by the FDA to treat adults with relapsing MS.
Reporting by Mrinalini Krothapalli in Bengaluru; Editing by Shounak Dasgupta