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Novartis Says Gilenya Showed Positive Clinical Outcomes In Phase III 2309 Study

12/15/2011 1:29 AM ET

Novartis AG (NVS: Quote) announced new data from the Phase III 2309 study showing patients with relapsing-remitting multiple sclerosis, or RRMS, treated with Gilenya, or fingolimod, had a statistically significant 48% reduction in annualized relapse rates at 24 months compared to placebo.

According to the company, study 2309 is the third Phase III clinical trial to demonstrate a significant reduction of relapse rates with Gilenya treatment in patients with RRMS.

Novartis noted that 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.

Moreover, safety and tolerability were broadly consistent with previous clinical trials.

"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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by RTT Staff Writer

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