Novartis therapy GilenyaTM reduced the risk of MS disability progression regardless of treatment history or disease severity, new analysis shows
April 11, 2011
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Gilenya delayed the progression of disability both for patients who were previously treated for their MS and for patients who had not received prior treatment
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11 scientific abstracts on Gilenya efficacy and safety will be presented at the American Academy of Neurology annual meeting
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Gilenya, first oral in a new class of drugs called S1P receptor modulators, is approved in more than 35 countries including US, Canada and Germany
Basel, April 11, 2011– A new analysis demonstrated that Gilenya(TM) (fingolimod) reduced the risk of disability progression in patients with relapsing-remitting multiple sclerosis (RRMS), regardless of treatment history. This analysis of the phase III two-year FREEDOMS study is one of 11 abstracts on Gilenya being presented at the 63rd annual meeting of the American Academy of Neurology (AAN).
“In developing Gilenya, Novartis initiated a large clinical trial program that would provide the MS community with robust data to define the efficacy and safety profile of this oral treatment for relapsing forms of MS,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “Our scientific presence at AAN is evidence of our commitment to continued research and ongoing reporting of clinical information to physicians and patients.”
The primary endpoint for the two-year FREEDOMS study was relapse rate, in which Gilenya reduced relapses by 54% compared to placebo (p<0.001). In a key secondary endpoint, Gilenya showed a 30% reduction (p<0.05) in the risk of 3-month confirmed disability progression as compared to placebo over two years.
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