FDAnews Drug Daily Bulletin

Amicus to Delay Amigal NDA Filing Per FDA Remarks

June 26, 2013
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