- A new analysis of two Phase 3 trials shows that previously-treated patients with highly-active relapsing multiple sclerosis (RMS) who were treated with Novartis' Gilenya (fingolimod) had a 6x greater likelihood of achieving "no evidence of disease activity" across four key measures of disease activity compared to placebo over two years (p<0.0001). The disease status, called NEDA4, is achieved when an RMS patient has no relapses, no new MRI lesions, no MS-related brain shrinkage and no disability progression. It provides physicians with a more complete picture of an RMS patient's disease and response to therapy.
- A separate analysis of the data also confirmed that, after one year of treatment, RMS patients on Gilenya were 2x as likely to achieve NEDA4 as patients on Biogen's (NASDAQ:BIIB) Avonex (interferon beta-1a).
- The data were presented at the 67th American Academy of Neurology Annual Meeting in Washington, D.C.
- Gilenya is approved in the U.S. for the first-line treatment of RMS in adults and in Europe for adult patients with highly-active RMS.