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Protalix Submits BLA To FDA For Pegunigalsidase Alfa For Treatment Of Fabry Disease

Protalix BioTherapeutics Inc. (PLX), together with its development and commercialization partner Chiesi Global Rare Diseases, announced the submission of a Biologics License Application to the U.S. Food and Drug Administration 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 a-galactosidase-A investigational product candidate.

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.

Upon the BLA approval, if approved, the company will be eligible to receive a milestone payment from Chiesi.

Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal a-Galactosidase-A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body.

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