Posted by Michael Wonder on 28 May 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce submission of biologics license application to U.S. FDA for pegunigalsidase alfa for the treatment of Fabry disease
28 May 2020 - Protalix BioTherapeutics together with its development and commercialisation partner Chiesi Global Rare Diseases, today announced the submission of a biologics license application to the U.S. FDA for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's accelerated approval pathway.
Pegunigalsidase alfa, or PRX-102, was granted fast track designation by the FDA in January 2018.
Pegunigalsidase alfa is the Company's purposefully-designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate.
