Protalix and Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver therapies and solutions for people affected by rare diseases, announced the resubmission on November 9 of a biologics license application, or BLA, to the FDA, for PRX-102 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 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 upon BLA approval. Protalix and Chiesi anticipate that the FDA will complete its review of the resubmission within six months of receipt.
Published first on TheFly
