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# Protalix, Chiesi Resubmit Fabry Disease BLA
- URL: https://www.fdaweb.com/protalix-chiesi-resubmit-fabry-disease-bla/
- Published: 2022-11-14T12:00:00.000Z
- Updated: 2026-09-14T18:06:21.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153188

Protalix BioTherapeutics and Chiesi Global Rare Diseases have resubmitted a BLA for PRX–102 (pegunigalsidase alfa) for treating adult patients with Fabry disease. The companies describe pegunigalsidase alfa as a purposefully-designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate.

Last year, the agency issued a complete response letter on the BLA, which at the time did not cite any safety or efficacy concerns regarding the therapy ([see earlier story](https://www.fdaweb.com/protalix-gets-complete-response-on-fabry-therapy/)), according to Protalix. FDA indicated then that because Genzyme recently converted Fabrazyme’s accelerated approval to full approval, this must be “addressed in the context of any potential resubmission seeking accelerated approval of PRX 102,” the company said.

Protalix and Chiesi appear to be seeking traditional BLA approval and they say the 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 3 clinical program including the BALANCE study, the BRIDGE study and the BRIGHT study, as well as the Phase 1-2 clinical trial of PRX–102\. The Phase 1-2 data includes data compiled from the related extension study succeeding the Phase 1-2 study. The BLA resubmission also includes safety data compiled from the ongoing Phase 3 extension studies of PRX–102.”