28 October 2022 - FDA issues deferred action letter on AT-GAA regulatory filing due to the inability to conduct required manufacturing site inspection prior to the PDUFA action date.
Amicus Therapeutics today announced that the US FDA has deferred action on the biologics license application for cipaglucosidase alfa, the biologic component of AT-GAA.
Due to restrictions on travel related to COVID-19, the FDA was unable to conduct the required inspection of the WuXi Biologics manufacturing site in China during the review cycle.