Posted by Michael Wonder on 11 May 2022
Amicus Therapeutics receives notification of PDUFA date extensions for AT-GAA
10 May 2022 - Amicus Therapeutics today announced that the U.S. FDA has extended the review period by 90 days for the biologics license application for cipaglucosidase alfa and the new drug application for miglustat, the two components of AT-GAA.
The revised PDUFA action dates for miglustat and cipaglucosidase alfa are 29 August 2022 and 29 October 2022, respectively.
