Novartis said a Phase III PARADIGMS study comparing oral fingolimod with interferon beta-1a intramuscular injections found that the former lead to a reduction in the amount of relapses in adolescents with multiple sclerosis (MS) over a two-year period.
The study is meant to find treatments for children adolescents with MS that are safe and effective, Novartis said in a release. It is the first study to evaluate treatments in pediatric MS, a disorder of the central nervous system that disrupts normal brain, optical nerve and spinal cord functions and can make participating in daily activities difficult.
"Living with MS is a tremendous challenge at any age. However, its appearance in children and adolescents, when these young individuals should be developing and focusing on their future, can be devastating," Vas Narasimhan, global head of drug development and chief medical officer at Novartis, said in the release.
Although fingolimod is not yet approved for treatment of MS in adolescence, Novartis will complete an analysis of the recent data and talk to health authorities about the next steps regarding submission.
"With no specifically approved treatment options based on a thorough study such as PARADIGMS, the risk of long-term disease progression in (pediatric MS) patients is much greater," Narasimhan said in the release. "The outcome of this study is very exciting news for the MS patient community, all of whom benefit from potential advances in high-quality, evidence-based care such as this. I would like to thank the young people with MS and their families, physicians and nurses who participated and made this landmark study possible."