Amicus Therapeutics Provides EU Regulatory Update for AT-GAA
November 07, 2022 at 12:20 PM EST
PHILADELPHIA, Nov. 07, 2022 (GLOBE NEWSWIRE) -- 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.