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Phase III trial confirms safety profile of Novartis MS pill

World News | December 15, 2011


Kevin Grogan

Phase III trial confirms safety profile of Novartis MS pill

A couple of days after confirming that a patient died 24 hours after starting therapy with Gilenya, Novartis has posted positive data from another large late-stage trial of its multiple sclerosis pill.

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

The company noted that "safety and tolerability were broadly consistent" with the profile seen in 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 firm said it was looking into whether the drug had caused the death of a man who had just started therapy. Novartis  noted that "a role for Gilenya can neither be confirmed nor excluded at this time."

David Epstein, head of Novartis Pharma, said the trial confirms the efficacy of Gilenya "across several key measures". He added that "with more than 20,000 patient years of fingolimod exposure to date", the pill "continues to demonstrate its value to patients and the MS community". The full data will be presented at a scientific congress next year.

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