Posted by Michael Wonder on 29 Sep 2021
U.S. FDA accepts filings for Amicus’ AT-GAA for the treatment of Pompe disease
29 September 2021 - FDA sets PDUFA target action date of 29 May 2022 for the new drug application and 29 July 2022 for the biologics license application.
Amicus Therapeutics today announced that the U.S. FDA) has accepted for review the biologics license application for cipaglucosidase alfa and the new drug application for miglustat for AT-GAA, the Company’s investigational two-component therapy for the treatment of Pompe disease.
