Novartis announces presentation of data at AAN showing Gilenya® slowed the rate of brain volume loss in MS patients

Novartis International AG / Novartis announces presentation of data at AAN showing Gilenya® slowed the rate of brain volume loss in MS patients . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• MS patients have accelerated brain volume loss (up to 3-5 times faster than people without MS), which is associated with physical & cognitive loss of function

• Data at AAN showed significantly more Gilenya-treated patients (vs. patients on placebo) had brain volume loss rates comparable to people without MS

• Brain volume loss, one of the four key measures of MS disease activity, starts early in the disease and is a predictor of long-term disability

The digital press release with multimedia content can be accessed here:

Basel, April 30, 2014 - Novartis announced today new data presented at the 66^th American Academy of Neurology (AAN) Annual Meeting, which showed more patients with relapsing multiple sclerosis (MS) treated with Gilenya^® (fingolimod) achieved an average annual rate of brain volume loss within the range of those expected for healthy adults of a similar age vs. those patients taking placebo[1]. Everybody loses brain volume (also referred to as "shrinkage of the brain") as they age[1],[2], but people with MS experience shrinkage of the brain up to three to five times faster[1]-[4]. This acceleration starts early in people with relapsing MS, even before symptoms are apparent[5]-[8]. 

"These data are impressive as they show that Gilenya slows brain volume loss in relapsing MS patients, an important indicator of disease activity," said David Epstein, Division Head, Novartis Pharmaceuticals. "Brain volume loss is a topic of growing interest to the MS community as reducing it may benefit patients by slowing long term physical and cognitive loss of function."

Based on growing evidence, damage from lesions and brain volume loss leads to worsening of the symptoms for MS (e.g. problems walking or difficulties with mental tasks)[5],[9]-[11]. Brain volume loss is  strongly associated with long-term disability[4],[5],[11]-[13].

About the data at AAN
The average brain volume loss in people without MS ranges from 0.2% to 0.4% per year[1],[2], depending on age (as described in the literature). MS patients typically lose brain volume at an approximate rate of  0.5% to 1.35% per year[1],[3],[4].

Post hoc analyses presented at AAN showed that significantly more Gilenya treated patients had annual brain volume loss rates below 0.4% (within the range of people without MS), compared to placebo (37.2% vs 26.7% respectively, p=0.0001)[1].This effect was consistent across different age groups[1].