Novartis has released top-line data showing that Gilenya significantly reduced relapses in children and adolescents with multiple sclerosis.
The drug giant says data from the Phase III PARADIGMS study show that Gilenya (fingolimod) resulted in a “significant and clinically meaningful reduction” in the annualised relapse rate over a period of up to two years, compared to interferon beta-1a intramuscular injections.
Also, the drug’s safety profile was consistent with that seen in other clinical trials, with overall more adverse events reported in the interferon group, according to the firm.
Commonly diagnosed during adolescence, paediatric MS is associated with relapses that are more frequent and often more severe than those seen in adults with the condition.
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 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 PARADIGMS study is the first ever randomised, controlled Phase III study of a disease-modifying therapy in paediatric MS. Results of the trial will be presented at the ECTRIMS-ACTRIMS meeting next month in Paris, France.
Gilenya is approved in the US for the first-line treatment of relapsing forms of MS in adults and in the EU for adult patients with highly-active relapsing-remitting MS defined as either high disease activity despite treatment with at least one DMT, or rapidly-evolving severe RRMS.