Analysis of long term effect of Gilenya (fingolimod) in patients with relapsing MS- Novartis

Novartis has announced 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 or 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.

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.