Protalix, Chiesi Global Rare Diseases announce FDA acceptance of PRX-102 BLA

Protalix and Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced that the FDA has accepted the resubmitted Biologics License Application, or BLA, for pegunigalsidase alfa, or PRX-102, for the proposed 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 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.