ARTICLE | Company News
Priority Review for Amicus' migalastat
February 12, 2018 10:06 PM UTC
FDA accepted and granted Priority Review to an NDA from Amicus Therapeutics Inc. (NASDAQ:FOLD) for migalastat (AT1001) to treat Fabry's disease in patients 16 years and older who have amenable mutations. The PDUFA date is Aug. 13.
The NDA is based on data from the Phase III FACETS and ATTRACT trials. ...
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