December 15, 2011
Novartis International AG / Novartis drug Gilenya® showed positive clinical outcomes for relapsing-remitting MS patients in third large Phase III clinical trial . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
- * Once-daily oral MS medicine showed a 48% relative reduction in annualized relapse rate, meeting primary endpoint in Phase III placebo-controlled study
- * Significant reduction in brain volume loss demonstrated, reinforcing strong efficacy benefit in key secondary endpoint
- * Safety and tolerability were broadly consistent with previous clinical trials
Basel, December 15, 2011 – Novartis announced today new data from the Phase III 2309 study showing patients with relapsing-remitting multiple sclerosis (RRMS) treated with Gilenya® (fingolimod) had a statistically significant 48% reduction in annualized relapse rates (ARR) at 24 months compared to placebo. Study 2309 is the third Phase III clinical trial to demonstrate a significant reduction of relapse rates with Gilenya treatment in patients with RRMS. The two previous Gilenya studies involved a two-year, placebo-controlled trial and a one-year, head-to-head trial against interferon-beta-1a (IM) in which the once-daily oral medicine showed a 54% and a 52% relative reduction in ARR, respectively[1],[2].
A reduction of brain volume loss, a pre-defined key secondary endpoint for study 2309, also achieved statistical significance for Gilenya-treated patients compared to placebo. Brain volume loss is valued as a predictor of long-term disability[3] and study 2309 is the third Phase III clinical trial where Gilenya demonstrated high efficacy in this MRI (magnetic resonance imaging) measure compared to control.
“Study 2309 confirms the efficacy of Gilenya across several key measures, including reductions in annualized relapse rate and reductions in brain volume loss,” said David Epstein, Head of the Pharmaceuticals Division at Novartis Pharma AG. “With more than 20,000 patient years of fingolimod exposure to date, Gilenya continues to demonstrate its value to patients and the MS community. We are looking forward to presenting the full data to the clinical community at a scientific congress next year.”
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