Novartis therapy shows benefits for young people with multiple sclerosis

Novartis has announced new clinical trial data that demonstrates the strong performance of fingolimod in the treatment of young people with multiple sclerosis (MS).

Results from the phase III PARADIGMS study have highlighted the safety and efficacy of oral once-daily fingolimod in children and adolescents aged ten to 17 with MS, with the trial being the first phase III study of a disease-modifying therapy in paediatric MS.

Fingolimod was shown to result in a significant and clinically meaningful reduction in the number of relapses in this patient population over a period of up to two years, while its safety profile was consistent with that seen in other clinical trials.

Novartis will now carry out a thorough analysis of the data before holding discussions with health authorities to agree on next steps for regulatory filings.

Vas Narasimhan, global head of drug development and chief medical officer at Novartis, said: "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."

Fingolimod is approved in the EU for adult patients with highly-active relapsing-remitting MS under the brand name Gilenya. It has not yet been approved as a paediatric MS therapy in any country.

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