Protalix BioTherapeutics, Inc. and Chiesi Global Rare Diseases, a business unit of the Chiesi Group announced that the FDA has accepted the resubmitted Biologics License Application (BLA) for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease. Pegunigalsidase alfa is a purposefully-designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate. The FDA indicated in the BLA filing communication letter that the resubmitted BLA was considered a complete, class 2 response and set an action date of May 9, 2023, under the Prescription Drug User Fee Act (PDUFA).
As announced last month, on November 9, 2022, a BLA was resubmitted to the FDA for PRX–102 for the treatment of adult patients with Fabry disease. The BLA resubmission includes a comprehensive set of clinical and manufacturing data. The data were 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 including the BALANCE study, the BRIDGE study and the BRIGHT study, as well as the Phase I/II clinical trial of PRX–102. The Phase I/II data includes data compiled from the related extension study succeeding the Phase I/II study. 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 Chiesi.
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