FOLD - Amicus says no oral explanations in EU for lead program

Amicus Therapeutics ( NASDAQ: FOLD ) announced Monday that an advisory panel of the European Medicines Agency (EMA) would not conduct oral explanations for experimental therapies miglustat and cipaglucosidase alfa that make up its lead program, AT-GAA.

The update comes after the EMA’s Committee for Medicinal Products for Human Use (CHMP) announced the agenda for its November meeting this morning, indicating possible oral explanations on Nov. 9 for two treatments.

“The Company has now been informed that oral explanations will not take place as originally anticipated,” Amicus ( FOLD ) added. An oral explanation is a key event in the EU marketing authorization process for a drug.

The company still expects the panel to decide on AT-GAA in December, Amicus ( FOLD ) said, cautioning that potential timeline changes are, however, under consideration.

In December 2021, Amicus ( FOLD ) announced that the EMA validated its marketing applications for AT-GAA for the rare genetic disorder Pompe disease .

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