Protalix Biotherapeutics, Inc., (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and its development and commercialization partner, Chiesi Farmaceutici S.p.A. (Chiesi), an international research-focused healthcare group, today announced an agreement with the U.S. Food and Drug Administration (FDA) for the Initial Pediatric Study Plan (iPSP) for pegunigalsidase alpha, or PRX-102. The companies reported the news after completing discussions with the FDA and receiving confirmation in an official “Agreement Letter” which outlines an agreed approach to address the needs of pediatric patients with Fabry disease.
PRX-102 is the Company’s plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A candidate for the treatment of Fabry disease. PRX-102 has the potential to be approved for adult patients with Fabry disease under the FDA’s Accelerated Approval pathway.
“Proceeding with the pediatric study plan for PRX-102 marks an important milestone in our goal of bringing an alternative to the Fabry patient community which is in need of better treatment options other than those currently available,” said Dror Bashan, Protalix BioTherapeutics’ President and Chief Executive Officer.
Together with our partner Chiesi, we value this pediatric study as a new opportunity to potentially bring a new treatment option to the entire Fabry community.” said Dr. Raul Chertkoff, Protalix BioTherapeutics’ Vice President, Medical Affairs.
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The Company and Chiesi have previously reported that they expect to submit a Biologics License Application (BLA) to the FDA under an Accelerated Approval pathway. Based on prior discussions with the FDA, the companies believe that the nonclinical data, the clinical data, the safety database and manufacturing data are sufficient to support the BLA submission.
Source: Biospace
