Novartis looks to new measure of Gilenya outcomes
pharmafile | October 8, 2015 | News story | Research and Development | fingolimod, gilenya, multiple sclerosis, relapsing multiple sclerosis
Novartis says a new analysis from two Phase III trials reinforces the long-term efficacy profile of its MS treatment Gilenya.
The analysis evaluated the proportion of Gilenya (fingolimod) patients with relapsing multiple sclerosis (RMS) who achieved ‘no evidence of disease activity’ (NEDA-4) every year over seven years.
The clinical outcome measure NEDA-4 is achieved when a patient has no relapses, MRI lesions, MS-related brain shrinkage and disability progression.
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 in year three. Patients on continuous Gilenya treatment showed that, 31.2% to 44.8% had NEDA-4-status in each of the year’s three to seven.
Vas Narasimhan, Novartis global head of development, says: “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.”
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 doctors to predict long-term disability and brain shrinkage outcomes better than just assessing relapses, MRI lesions and disability progression.
The Swiss firm says these findings support the importance of assessing RMS with NEDA-4 to enable a more reliable prediction of long-term disease outcomes.
Yasmita Kumar
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