Novartis trials’ revelations

Data from two Novartis phase III clinical trials show that adding brain shrinkage (brain volume loss) to an existing tool to assess multiple sclerosis (MS) disease activity (m-Rio) will give a more precise prediction of the likelihood of future disability progression.

MS is a chronic disorder of the central nervous system that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss.

It results in an increasing loss of both physical and cognitive (e.g. memory) function. A disease that most often begins in early adulthood, MS affects approximately 2.3 million people worldwide.

A pooled analysis from the two-year Freedoms and Freedoms II trials also further confirm the high efficacy of Fingolimod in previously treated patients with highly-active relapsing MS. In the trials, patients on fingolimod achieved no evidence of disease activity (Neda) across four key measures: relapses, MRI lesions, brain shrinkage and disability progression. Achieving Neda is especially critical for highly-active RMS patients, who are likely to lose more physical and cognitive functions over time despite being treated.

The Fingolimod clinical trial data was presented at the 67th American Academy of Neurology annual meeting in Washington, DC, last April 18-25. Developed by Novartis, Fingolimod is the only oral disease-modifying therapy to impact the course of relapsing MS with high efficacy across four key measures of disease activity: relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression.

Accurate assessment

“Accurate assessment of disease activity is key to guide treatment decisions in relapsing MS. These data on fingolimod and new methods of assessing the impact of MS have the potential to give physicians a more comprehensive picture of an individual’s disease and allow patients to better understand their MS,” said Dr.

Ludwig F. Damian, consultant neurologist.

“Novartis is committed to innovation beyond the research and development of new treatments to help physicians and patients improve how MS is managed,” said Dr. Nikolaos Tripodis, Novartis Healthcare Philippines president and managing director.

Fingolimod is a prescription medication and should be taken only under the supervision of a physician.