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Submissions to Seek Approval in both ERT Naïve and ERT Switch Pompe Patients Completion of Rolling Biologics License Application On-Track by end of 2Q21 PHILADELPHIA, May 03, 2021 (GLOBE NEWSWIRE) Amicus Therapeutics (NASDAQ:FOLD) today announced the completion of a successful Type B Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) for AT-GAA (cipaglucosidase alfa co-administered with miglustat), its investigational two-component therapy for the treatment of Pompe disease. Based on this formal pre-BLA meeting and the final written communication received from the FDA, Amicus intends to complete the rolling BLA submission for cipaglucosidase alfa and submit a New Drug Application for miglustat.

United statesAndrew faughnanDiana mooreJohnf crowleyJeff castelliAmicus therapeuticsEuropean medicines agencyDrug administrationHead of global corporate communicationsExisting data support regulatorySeek approvalPompe patientsRolling biologics license application on trackTypeb pre biologics license applicationNew drug applicationChief executive officer