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Benzinga
Benzinga
Technology
Ragothaman Srinivasan

FDA Extends Review Of Amicus Therapeutics' AT-GAA For The Treatment Of Pompe Disease By Three Months

FDA Amicus Disease United States

The U.S. Food and Drug Administration (FDA) has extended the review period by 90 days for Amicus Therapeutics’ (NASDAQ:FOLD) two components of AT-GAA submission, Biologics License Application (BLA) for cipaglucosidase alfa and the New Drug Application (NDA) for miglustat, for the treatment of Pompe disease.

The regulatory agency has set a new PDUFA goal date of August 29, 2022 for miglustat and October 29, 2022 for cipaglucosidase alfa.

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