Gilenya® data confirm reducing brain shrinkage matters for people with MS due to its association with long-term disability progression

Novartis International AG / Gilenya® data confirm reducing brain shrinkage matters for people with MS due to its association with long-term disability progression . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Brain shrinkage is associated with a loss of physical and cognitive function and occurs at a faster rate in people with MS than those without the disease
   

New data showed patients who had the highest rates of brain shrinkage (brain volume loss) at two years had a higher risk of disability progression at four years
 

Separate analyses showed that patients continuously treated with Gilenya for six years had sustained low rates of brain shrinkage

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Basel, Sept 10, 2014 - Novartis announced today that new data presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, reinforces the clinical importance of measuring brain shrinkage (brain volume loss) in multiple sclerosis (MS). An association between the rate of brain shrinkage and increased risk of long-term disability progression was confirmed in patients with MS[1]. In pooled data from the phase III FREEDOMS core and extension studies, patients were categorized into four groups (quartiles) based on the mean change in brain volume from the start of the study to year-two. The analysis showed that 24.2% of patients who had the highest rate of brain shrinkage at 2 years had confirmed six-month disability progression at four years, compared to 15.4% of patients with the lowest rate of brain shrinkage (p=0.018)[1].

A separate analysis from the long-term follow-up extension study LONGTERMS, showed that the rate of brain shrinkage in patients treated with Gilenya^® (fingolimod) remained similar throughout the six-year period, between 0.33% and 0.46%[2]. This was broadly in the range you would expect to see in people without MS, while the typical rate of brain shrinkage experienced by patients with MS is approximately 0.5% to 1.35% per year[3],[4],[5],[6].

"Novartis is committed to generating data that advances science and clinical practice to improve the outcomes of patients. These new findings strengthen the link between brain shrinkage and long-term disability progression, supporting the significance of brain shrinkage for people with MS," said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals. "The new data showing sustained low rates of brain shrinkage in Gilenya-treated patients with MS are reassuring because of the chronic debilitating nature of the disease."