Posted by Michael Wonder on 02 Dec 2020
Amicus Therapeutics initiates rolling biologic license application to the U.S. FDA for AT-GAA in late-onset Pompe disease
1 December 2020 - On track for completing the BLA submission in 1H2021.
Amicus Therapeutics today announced the initiation of the rolling biologics license application submission to the U.S. FDA for AT-GAA, its investigational two-component therapy for the treatment of late onset Pompe disease.
The FDA earlier this year authorised Amicus to proceed with a rolling BLA submission.
