Protalix BioTherapeutics, Inc.'s Pegunigalsidase Alfa Receives Fast Track Designation from the U.S. Food and Drug Administration
January 31, 2018 at 06:00 pm IST
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Protalix BioTherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pegunigalsidase alfa, or PRX-102, the company’s plant cell-expressed recombinant, pegylated, cross-linked a-galactosidase-A candidate for the treatment of Fabry disease. The FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines for serious conditions that fill an unmet medical need. Pegunigalsidase alfa is currently being studied globally in three phase III clinical trials. Enrollment in each of the trials continues to progress and estimated timelines for top-line data announcements will be announced upon completion of enrollment for each individual trial.
Protalix BioTherapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. In addition, the Company is developing PEGylated uricase, or PRX-115, for the treatment of severe gout, Long Acting (LA) DNase I, or PRX-119, for the treatment of NETs-related diseases, and other technologies and preclinical assets. Its product, Elelyso is an enzyme replacement therapy (ERT) for the treatment of patients with Gaucher disease. Its ProCellEx platform is being used to manufacture both of its approved and marketed products as well as PRX-115 and PRX-119. PRX-115, a plant cell-expressed recombinant PEGylated Uricase (urate oxidase)- a chemically modified enzyme under development for the potential treatment of severe gout. PRX-119 is a plant cell-expressed PEGylated recombinant human DNase I product candidate.
PROTALIX BIOTHERAPEUTICS, INC. 
