The FDA approved a pediatric indication for Novartis' multiple sclerosis drug Gilenya, the drugmaker announced May 11.
The agency previously approved Gilenya, a disease-modifying therapy, for adults with relapsing forms of multiple sclerosis. The treatment may now also be used for children ages 10 and up with the same condition.
"We now finally have an FDA-approved treatment for children and adolescents with relapsing MS," said Brenda Banwell, MD, chief of the division of neurology at Children's Hospital of Philadelphia, who served as co-principal investigator in a clinical trial to support the pediatric approval. "Repeated relapses are more common in young people with MS than in adults, so this is heartening news for patients and their families."