2:06 PM
 | 
Feb 12, 2018
 |  BC Extra  |  Company News

Priority Review for Amicus' migalastat

Editor's Note: This article was updated on Feb 12, 2018 at 4:44 PM PST

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...

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