Phase III Trial Confirms Safety of Novartis’ Gilenya

Novartis LogoA few days after confirming that a patient died 24 hours after beginning treatment with Gilenya, Novartis today announced positive data from an additional major late-stage study of their multiple sclerosis drug.

Results from the 1, 083-patient Phase III 2309 trial revealed that sufferers with relapsing-remitting multiple sclerosis (MS) treated with Gilenya (fingolimod) had a 48% decline in annualised relapse rates at 24 months compared to placebo.  Study 2309 is the third late-study to show a substantial reduction of relapse rates with Gilenya, while decline of brain volume loss, a secondary endpoint for the study, also attained statistical significance.

Brain volume loss is valued as a predictor of long-term disability and the trial is the third Phase III clinical trial where Gilenya demonstrated high efficacy in this MRI (magnetic resonance imaging) measure compared to placebo.

Novartis noted that “safety and tolerability were broadly consistent” with the profile obtained from the previous Phase III clinical trials.  “There were no deaths in fingolimod-treated patients in the trial,” Novartis stressed.  Study 2309 was primarily performed to provide specific safety data for the Gilenya New Drug Application submitted to US regulators in December 2009.

Earlier this week, the corporation declared that they were looking into whether the drug had caused the decease of a man who had just begun therapy.  Novartis commented that “a role for Gilenya can neither be confirmed nor excluded at this time.”

David Epstein, head of the Pharmaceuticals Division at Novartis Pharma, said the trial confirms the effectiveness of Gilenya “across several key measures”.  He added that “with more than 20,000 patient years of fingolimod exposure to date”, the drug “continues to demonstrate its value to patients and the MS community”.  The full data will be presented at a scientific congress in 2012.


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