Posted by Michael Wonder on 14 May 2021
BridgeBio Pharma receives FDA fast track designation for investigational gene therapy for congenital adrenal hyperplasia
14 May 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation to BBP-631, an investigational adeno-associated virus 5 gene therapy designed for the treatment of congenital adrenal hyperplasia.
Additionally, BBP-631 was granted rare paediatric disease designation by the FDA and has received orphan drug designation by the FDA and EMA.
