A phase III Paradigms study in paediatric multiple sclerosis (MS) has met its primary end point, showing a significant reduction in the occurrence of relapses with Gileyna (also known as fingolimod) versus interferon beta-1a.
The study investigated the safety and efficacy of oral once-daily Gilenya, in children and adolescents (ages 10 to 17) with MS.
The data shows that oral fingolimod resulted in a significant and clinically meaningful reduction in the number of relapses (analysed relapse rate) in this patient population over a period of up to two years, compared to interferon beta-1a intramuscular injections.
The Paradigms study is the first ever randomised, controlled Phase III study of a disease-modifying therapy (DMT) in paediatric MS.
“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,” said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. “With no specifically approved treatment options based on a thorough study such as Paradigms, the risk of long-term disease progression in these patients is much greater. 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.”
Results of the study will be presented at the 7th Joint ECTRIMS-ACTRIMS meeting, taking place October 25 - 28, 2017, in Paris, France.
Fingolimod is not currently approved for the treatment of paediatric MS. Novartis plans to complete a thorough analysis of the data and speak to health authorities to agree on the next steps for submission.