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Protalix, Chiesi: FDA Accepts Resubmitted BLA For Pegunigalsidase Alfa To Treat Fabry Disease

Protalix BioTherapeutics, Inc. (PLX) and Chiesi Global Rare Diseases, a business unit of the Chiesi Group, announced Monday that the U.S. Food and Drug Administration has accepted the resubmitted Biologics License Application or BLA for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease.

If approved, Protalix will be eligible to receive a milestone payment from Chiesi.

Protalix developes production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell based protein expression system.

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 or PDUFA.

It was on November 9 that the companies resubmitted the BLA 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, which were compiled from studies that involved more than 140 Fabry disease patients with up to five years of follow up.

The BLA resubmission also includes safety data compiled from the ongoing Phase III extension studies of PRX-102.

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