FDAnews Drug Daily Bulletin

Amicus to Delay Amigal NDA Filing Per FDA Remarks

June 26, 2013
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Amicus Therapeutics says it is holding off filing an NDA for its orphan drug Amigal to treat Fabry disease until it analyzes data from a second Phase III study as recommended by the FDA. Amicus and its partner GlaxoSmithKline said late last year that their crossover, placebo-controlled Phase III study of Amigal (migalastat HCL) showed some promise, but that its primary endpoint failed to meet statistical significance.
Washington Drug Letter