Posted by Michael Wonder on 11 Aug 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce U.S. FDA acceptance of biologics license application for pegunigalsidase alfa for the proposed treatment of Fabry disease and grants priority review
11 August 2020 - Protalix BioTherapeutics together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, an international research-focused healthcare group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease.
The BLA was submitted via the FDA's Accelerated Approval pathway. Pegunigalsidase alfa is the Company's purposefully designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate.
The FDA set an action date of 27 January 2021, under the Prescription Drug User Fee Act.
