logo
Share SHARE
FONT-SIZE Plus   Neg

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

Novartis AG (NVS) 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."

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Delta Air Lines Inc. (DAL) pilots, represented by the Air Line Pilots Association International, are picketing on Friday at several airports across the country. The pilots said the picketing was to raise the sense of urgency in ongoing contract negotiations. The negotiations between the pilots... Charter Communications, and its recently acquired subsidiary Time Warner Cable, have been regularly overcharging its consumers to a tune of $7.2 million per year, according to a report from the U.S. Senate's Permanent Subcommittee on Investigations. According to the report, Time Warner Cable over-billed... Popular photo sharing network Instagram is adding a new translation button on its pages, so that the global crowd can read and enjoy the captions and comments given for the photographs uploaded. The new update will be available from next month onward.
comments powered by Disqus
Follow RTT