Amicus Therapeutics (NASDAQ:FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today provided an EU regulatory update for AT-GAA. Earlier this morning, the Committee for Medicinal Products for Human Use (CHMP) issued the agenda for their November meeting indicating possible oral explanations for miglustat and for cipaglucosidase alfa on November 9th. The Company has now been informed that oral explanations will not take place as originally anticipated. The Company continues to prepare for a CHMP opinion on AT-GAA as early as December 2022 and will assess any potential change in timelines.
About AT-GAA
AT-GAA is an investigational two-component therapy that consists of cipaglucosidase alfa (ATB200), a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures, particularly bis-phosphorylated mannose-6 phosphate (bis-M6P) glycans, to enhance uptake into cells, administered in conjunction with miglustat (AT2221), a stabilizer of cipaglucosidase alfa.
