A new analysis demonstrated that Novartis' Gilenya (fingolimod) reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis (RRMS), regardless of treatment history. This analysis of the phase III two-year FREEDOMS study is one of 11 abstracts on Gilenya being presented at the 63rd annual meeting of the American Academy of Neurology (AAN).
The primary endpoint for the two-year FREEDOMS study was relapse rate, in which Gilenya reduced relapses by 54% compared to placebo (p
The FREEDOMS analysis showed that 0.5 mg Gilenya-treated patients who were new to therapy (n=493) had a 37% reduction in the risk of 3-month confirmed disability progression compared to placebo (HR: 0.63; 95% CI: 0.41-0.95) while those previously treated with alternate therapies (n=350) Gilenya 0.5 mg led to a 30% reduction in risk (HR: 0.70;95% CI:0.43-1.14). Consistent favorable effects on disability progression were observed for Gilenya-treated patients compared to placebo for subgroups defined by age, gender, and disease severity as defined by EDSS score, relapse activity prior to study, magnetic resonance imaging (MRI) lesion burden or lesion activity at the time of the start of the study.