Highlighting a major shift at the FDA, regulators put Amicus' once-spurned drug on fast track
In general, the FDA’s fast track designations don’t make news. The majority of new drugs which gain approval these days get some sort of special status — to the point that it isn’t so special anymore.
But when you’re Amicus Therapeutics $FOLD, and you’re bouncing back from a stinging setback for the lead drug migalastat, it’s a special moment to announce that the agency has put your drug for Fabry disease on the fast track. Regulators are essentially promising to make things happen fast as Amicus lines up a new filing before the end of this year, though it’s not a guarantee of any kind.
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