Long-term efficacy profile of Novartis' Gilenya reinforced by study

New analysis from Phase III trials has reinforced the long-term efficacy profile of Gilenya (fingolimod) from Swiss pharma giant Novartis (VX: NOVN).

The analysis looked at the proportion of Gilenya patients with relapsing multiple sclerosis achieving ‘no evidence of disease activity’ (NEDA-4) each year for seven years. This is achieved when a patient has no relapses, MRI lesions, MS-related brain shrinkage and disability progression. The follow-up pooled data from the FREEDOMS and FREEDOMS II core and extension trials. In the first year, 27.1% of patients on Gilenya achieved NEDA-4 compared to 9.1% on placebo. Switching to Gilenya from placebo after year two doubled the proportion of patients achieving NEDA-4 in year three, from 12.7% to 27.4%. Of the patients on continuous Gilenya treatment, 31.2% to 44.8% had NEDA-4 status in each of years three to seven.

Van Narasimhan, Novartis global head of development, said: "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. 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."