New analyses of pooled data from the FREEDOMS and FREEDOMS II trials will be presented at the 66th American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania, and will show the consistent efficacy of Gilenya (fingolimod) on four key measures of multiple sclerosis (MS) disease activity - reducing relapses, new MRI lesion counts, brain volume loss and disability progression.
Demonstrating benefit on these four measures is important in order to improve the course of MS and ultimately address the loss of function (e.g. problems walking or difficulty with mental tasks) experienced by patients with MS. An additional analysis of FREEDOMS and FREEDOMS II will show that significantly more Gilenya-treated patients (vs. patients on placebo) had brain volume loss rates comparable to people without MS. Given that brain volume loss, measured by Magnetic Resonance Imaging (MRI), starts early in the disease course and is correlated with long-term disability (both physical and cognitive), a treatment benefit on this measure will be important for patients with MS.
"These new analyses provide further evidence of how Gilenya impacts four key measures of MS disease activity," said David Epstein, Division Head, Novartis Pharmaceuticals. "Additionally, new data reinforcing Gilenya's positive effect on brain volume loss are of significant interest to the MS community. People with MS lose brain volume up to three to five times faster than people without MS and these data will highlight the importance of a treatment that can minimize brain volume loss in patients."
Novartis is also presenting trial design information on PARADIGMS, the first controlled clinical trial investigating a disease-modifying therapy (DMT) in pediatric MS patients. In collaboration with regulatory agencies and international leaders in pediatric MS, Novartis has developed the PARADIGMS study to evaluate the efficacy and safety of fingolimod versus an injectable interferon beta 1-a treatment in pediatric patients treated for 24 months. Pediatric MS is uncommon, given that only 3-5% of all MS cases start in this age range. There are currently no approved treatments for pediatric MS, and no controlled studies of MS therapies have been conducted in this population.
Gilenya is the only oral disease modifying therapy (DMT) that works on four key measures of multiple sclerosis (MS) disease activity - relapses, MRI lesions, brain volume loss and disability progression.
Gilenya reduces both the distinct inflammatory lesions in the brain (focal damage) that can clinically manifest as relapses, and the ongoing, underlying damage in the brain (diffuse damage) that starts early in the disease. Diffuse damage often goes unnoticed, causes the loss of neurons and over time is associated with both physical and cognitive problems. Gilenya's reduction of both focal damage and diffuse damage is due to its impact on the inflammatory process (peripheral action) and its ability to enter the CNS and impact from within the CNS (central action). It is by addressing both focal and diffuse damage that the course of MS can be effectively impacted, helping to preserve a patient's physical (e.g. difficulty with walking) and cognitive (e.g. problems with mental tasks or memory) function.