FDA extends PDUFA date for PRX 102 in Fabry Disease.- Protalix BioTherapeutics and Chiesi

Protalix BioTherapeutics and Chiesi Global Rare Diseases announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company's Biologics License Application (BLA) seeking accelerated approval of PRX 102 (pegunigalsidase alfa) for the proposed treatment of adult patients with Fabry disease. The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021.The FDA accepted the BLA, granted Priority Review designation under FDA's Accelerated Approval pathway, and indicated that it is not currently planning to hold an advisory committee meeting to discuss the application. Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. The BLA submission includes a comprehensive set of preclinical, clinical, and manufacturing data compiled from the Company's completed Phase I/II clinical trial of pegunigalsidase alfa, including the related extension study succeeding the Phase I/II clinical trial, interim clinical data from the Phase III BRIDGE switch-over study and safety data from the Company's on-going clinical studies of PRX 102 in patients receiving 1 mg/kg every other week.