(RTTNews) - Biopharmaceutical company Protalix BioTherapeutics, Inc. (PLX) announced Monday the resubmission on Wednesday of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease.
Pegunigalsidase alfa is a purposefully-designed, long-acting recombinant, PEGylated, cross-linked a-galactosidase-A investigational product candidate.
The BLA resubmission includes a comprehensive set of clinical and manufacturing data, which was compiled from studies that involved more than 140 Fabry disease patients with up to five years of follow up including all three completed studies in the PRX-102 Phase III clinical program.
The BLA resubmission also includes safety data compiled from the ongoing phase III extension studies of PRX-102. If approved, Protalix will be eligible to receive a milestone payment from Italian pharmaceutical company Chiesi Farmaceutici S.p.A. upon BLA approval.
Protalix and Chiesi anticipate that the FDA will complete its review of the resubmission within six months of receipt.
The European Medicines Agency (EMA) is currently reviewing the marketing authorization application for PRX-102, and interactions with the EMA are ongoing.
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