PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[midastouch017]

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease

CARMIEL, Israel, Nov. 27, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Food and Drug Administration (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 pegunigalsidase alfa (PRX–102) 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.

As previously announced, 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.

https://finance.yahoo.com/news/protalix-biotherapeutics-chiesi-global-rare-115000678.html