JERUSALEM (dpa-AFX) - Protalix BioTherapeutics, Inc. (PLX), and Chiesi Global Rare Diseases said they received a Complete Response Letter from the FDA regarding the Biologics License Application seeking accelerated approval of pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease. The BLA submission for PRX-102 included a comprehensive set of preclinical, clinical, and manufacturing data compiled from the completed phase I/II clinical trial of PRX-102.
'While disappointing, we remain confident in the strength of our data and in the depth of our program,' said Dror Bashan, Protalix's President and Chief Executive Officer.
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