Quoted from http://www.reuters.com/article/2011/12/15/us-novartis-idUSTRE7BE0GM20111215
Gilenya trial could ease safety worries
ZURICH | Thu Dec 15, 2011 2:25am EST
ZURICH (Reuters) - A third late-stage trial of Novartis' multiple sclerosis drug Gilenya did not throw up any new safety issues with the pill, going some way to alleviating concerns about possible risks linked to the potential blockbuster.
The study results come just days after Novartis said it was looking into whether the pill had caused the death of a 59-year-old patient who had just started therapy.
But Novartis said there had been no deaths in patients treated with Gilenya on the trial and that safety and tolerability were broadly consistent with the safety profile of the medicine in previous Phase III trials.
This study, known as Study 2309, was mainly carried out to give specific safety data for the Gilenya New Drug Application that was submitted to the U.S. Food and Drug Administration at the end of 2009. Gilenya has since won approval there.
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