October 05, 2011 15:57
A summary of results released ahead of a presentation at the ECTRIMS meeting suggest that Biogen Idec’s experimental oral multiple sclerosis therapy BG-12 (dimethyl fumarate) revealed no new safety concerns. The drug also demonstrated similar efficacy when dosed twice or three times daily. An analyst at Jefferies and Company commented that “these data suggest a much stronger effect on MRI measures than would be expected from standard front-line injectable therapies.”
Initial results from the DEFINE trial, which enrolled more than 1200 patients with relapsing-remitting MS over two years, were released in April. Data showed that the experimental therapy cut the risk of relapse at two years by 49 percent and 50 percent in two and three daily doses, respectively, versus placebo. In addition, annualized relapse rates were reduced by 53 percent and 48 percent for the two and three daily doses, respectively, versus placebo. Biogen reported that the incidence of serious adverse events and infection was similar to that of placebo, and discontinuation rates were approximately 16 percent among patients given BG-12 and 13 percent among those given placebo.
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