The U.S. Food and Drug Administration (FDA) has extended the review period by 90 days for Amicus Therapeutics’ (NASDAQ:FOLD) two components of AT-GAA submission, Biologics License Application (BLA) for cipaglucosidase alfa and the New Drug Application (NDA) for miglustat, for the treatment of Pompe disease.
The regulatory agency has set a new PDUFA goal date of August 29, 2022 for miglustat and October 29, 2022 for cipaglucosidase alfa.
The review extension allows additional time for FDA to review information submitted by the Company as part of its ongoing reviews, and the timeline was not related to requests for any additional clinical data.
John F. Crowley, Chairman and Chief Executive Officer, said, ”We continue to work collaboratively with the FDA as it completes its review of the AT-GAA applications, We want to thank the FDA for its continued diligence during the review process. We remain deeply committed to bringing AT-GAA to as many people living with Pompe disease as quickly as possible and delivering on our promise to become the potential new standard of care.”
Pompe disease is a rare genetic disease that causes premature death and has a debilitating effect on people's lives. The U.S. represents the single largest geography for Amicus to positively impact the lives of people with Pompe disease.
Amicus Therapeutics is trading down at $6.70 in the after-hours session.
