BioCentury
ARTICLE | Clinical News

Priority Review for Amicus' migalastat

February 16, 2018 1:04 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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Amicus Therapeutics Inc.