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FDA Extends Review of Amicus Therapeutics’ AT-GAA for the Treatment of Pompe Disease by Three Months

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.

The review …

Full story available on Benzinga.com

Source: benzinga.com

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