News Feature | April 24, 2014

New Data Confirms Efficacy Of Novartis' Gilenya For MS Disease

By Estel Grace Masangkay

Novartis announced that new analyses of pooled data from its FREEDOMS and FREEDOMS II trials showed that significantly more Gilenya-treated patients had brain volume loss rates comparable to people without MS versus patients who were treated with placebo. The company said the new data confirms Gilenya’s efficacy across four key measures of MS disease activity.

Gilenya is currently the only oral disease modifying therapy (DMT) that has been shown to work on four key measures of multiple sclerosis (MS) disease activity. These are: relapses, MRI lesions, brain volume loss, and disability progression. The drug reduces both focal damage, the distinct inflammatory lesions in the brain that can clinically manifest as relapses, and diffuse damage which is the ongoing, underlying damage in the brain that starts early in the disease.

David Epstein, Division Head of Novartis Pharmaceuticals, said, “These new analyses provide further evidence of how Gilenya impacts four key measures of MS disease activity. 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.”

A treatment benefit in brain volume loss is significant for patients with MS as it usually starts early in the disease course and is correlated with long term physical and cognitive disability. Multiple sclerosis is a chronic disorder of the central nervous system (CNS) which disrupts the normal functions of the brain, optic nerve, and spinal cord. The disease’s debilitating effect on physical and cognitive abilities negatively impacts about 2.3 million people with MS around the world.

Data from the new analyses will be presented at the 66th American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania.