New extension study data with Novartis drug Gilenya® shows patients successfully treated for up to 7 years in relapsing MS

New data will be presented at the 64th annual meeting of the American Academy of Neurology (AAN) that support the efficacy and safety profile of Gilenya® (fingolimod), the only oral therapy approved to treat relapsing forms of multiple sclerosis (MS)[1],[2]. End Quote

(1888PressRelease) April 20, 2012 - Novartis will also showcase new data on its investigational compound BAF312 (siponimod), a selective modulator of the S1P receptor subtypes 1 and 5 (S1P1, -5R modulator) in its multiple sclerosis portfolio[3].

"The data being presented reinforce our confidence in the sustained efficacy and safety profile of Gilenya," said David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG. "We also are pleased to present encouraging data for our investigational compound BAF312 (siponimod). The clinical development of BAF312 demonstrates our commitment to developing new therapeutic options for the MS community."

New data presented on long-term efficacy and safety profile of Gilenya
New results from the phase III FREEDOMS extension study showed significant improvements in clinical and MRI measures in patients who switched from placebo (administered during the 24-month core study) to Gilenya (administered during the extension). 1033 patients completed the two-year, double-blind FREEDOMS 24 month core study. Of these, 90% of patients completed 3 years observation and 45% were followed for 4 years in this study before being transferred to the umbrella follow-up study (LONGTERMS). Patients who switched from placebo to Gilenya saw a 55% decrease in their annualized relapse rate (ARR) during the extension phase compared to the core phase (ARR [core] = 0. 29 vs. ARR [extension] 0.13; p

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