Long-term efficacy of Gilenya reinforced by new ‘no evidence of disease activity’ analysis in MS patients over seven years

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The FINANCIAL — Novartis announced on October 8 a new analysis from the phase III FREEDOMS and FREEDOMS II trials reinforcing the long-term efficacy profile of Gilenya (fingolimod).

The analysis evaluated the proportion of Gilenya patients with relapsing multiple sclerosis (RMS) achieving ‘no evidence of disease activity’ (NEDA-4) every year over seven years. NEDA-4 is achieved when a patient has no relapses, MRI lesions, MS-related brain shrinkage and disability progression. These data were presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, according to Novartis.

This follow-up analysis of pooled data from the FREEDOMS and FREEDOMS II core and extension trials was conducted to assess NEDA-4 each year for seven years in patients with RMS. The data showed that in the first year, 27.1% of patients on Gilenya achieved NEDA-4 compared to 9.1% on placebo. Switching from placebo to Gilenya after year two doubled the proportion of patients achieving NEDA-4 (12.7% to 27.4%) in year three. Of those patients on continuous Gilenya treatment, 31.2% to 44.8% had NEDA-4-status in each of the years three to seven.

“MS is a chronic debilitating disease and these data are important in showing the long-term efficacy of Gilenya, and the importance of early treatment to help improve long-term outcomes for patients,” said Vas Narasimhan, Novartis Global Head of Development. “Better understanding of the course of a person’s MS through assessment of NEDA-4 can help physicians identify the optimal, effective treatment approach as early as possible for their patients.”

A separate follow-up analysis of data from the FREEDOMS and FREEDOMS II trials also confirmed for the first time that assessment of RMS based on NEDA-4 allowed physicians to better predict long-term disability and brain shrinkage outcomes than just assessing relapses, MRI lesions and disability progression. NEDA-4 status over the first year was a significantly better predictor of disability and brain shrinkage over the subsequent five years, as measured by patients reaching a stage of severe disability (EDSS >=6: patients require a crutch to walk approximately 100m) (p<0.0127) or having more than 0.4% mean annual brain volume loss. These findings support the importance of assessing RMS with NEDA-4 to enable a more reliable prediction of long-term disease outcomes.


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