Novartis celebrates success of Gilenya in paediatric multiple sclerosis

Novartis has announced results of its Phase 3 study investigating the safety and efficacy of Gilenya (fingolimod) , finding that the drug met its primary endpoint in the treatment of multiple sclerosis (MS) in children and adolescents aged 10 to 17. The study marked the first-ever randomised, controlled Phase 3 trial of a disease-modifying therapy in paediatric MS.  

The drug was found to produce a "significant and clinically meaningful" reduction in annualised relapse rate over two years compared to interferon beta-1a intramuscular injections in its 215 participants.

Gilenya is designed to tackle four key areas of relapsing MS: MRI lesions, brain shrinkage, disability progression and relapses, achieving this through its reversible lymphocyte redistribution effect which targets focal and diffuse nervous system damage caused by the disease.

"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, Chief Medical Officer, and recently announced future CEO of 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. I would like to thank the young people with MS and their families, physicians and nurses who participated and made this landmark study possible," he continued.

The drug is approved in the US as a first-line treatment for relapsing MS in adults, and in highly-active relapsing-remitting MS in the EU.