By Colin Kellaher
Amicus Therapeutics Inc. on Wednesday said the U.S. Food and Drug Administration has accepted for review its applications for AT-GAA, a two-component therapy for the rare genetic disorder Pompe disease.
The Philadelphia biotechnology company said the agency set target action dates of May 29, 2022, for the cipaglucosidase alfa component and July 29, 2022, for the miglustat component.
Amicus said it is working toward additional regulatory submissions outside the U.S., with a European Union filing expected by the end of the year.
Write to Colin Kellaher at email@example.com
(END) Dow Jones Newswires
September 29, 2021 07:34 ET (11:34 GMT)Copyright (c) 2021 Dow Jones & Company, Inc.