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Amicus: FDA Accepts Filings for AT-GAA for Pompe Disease

By Colin Kellaher

 

Amicus Therapeutics Inc. on Wednesday said the U.S. Food and Drug Administration has accepted for review its applications for AT-GAA, a two-component therapy for the rare genetic disorder Pompe disease.

The Philadelphia biotechnology company said the agency set target action dates of May 29, 2022, for the cipaglucosidase alfa component and July 29, 2022, for the miglustat component.

Amicus said it is working toward additional regulatory submissions outside the U.S., with a European Union filing expected by the end of the year.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

September 29, 2021 07:34 ET (11:34 GMT)

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