Posted by Michael Wonder on 28 Nov 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce extension of PDUFA date for pegunigalsidase alfa for the proposed treatment of Fabry disease
27 November 2020 - Protalix BioTherapeutics today announced that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company's biologics license application seeking accelerated approval of pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease.
The FDA extended the PDUFA action date by three months to 27 April 2021, from 27 January 2021.
