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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. ....

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