PHILADELPHIA, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics, a patient-dedicated global biotechnology company focused on discovering, developing and delivering novel medicines for rare diseases, today announced the topline results of its Phase 3 PROPEL Pivotal Trial for AT-GAA (cipaglucosidase alfa and miglustat), its investigational two-component therapy for the treatment of late-onset Pompe disease (LOPD) that has previously received Breakthrough Therapy Designation from the U.S. FDA and the Promising Innovative Medicine designation from the MHRA in the United Kingdom. With consent from the FDA, the Company initiated a rolling Biologics License Application (BLA) in the fourth quarter of 2020. Amicus plans to complete the BLA submission in the second quarter of this year and anticipates additional regulatory submissions in the European Union and in other geographies throughout 2021.
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