Protalix BioTherapeutics and Chiesi Farmaceutici Announce Successful pre-BLA Meeting with FDA for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the United States

FDA indicated that existing clinical data, nonclinical data, safety database and manufacturing data will support a Biologics License Application submissionNo additional clinical trials are necessary for BLA submission, expected by April of 2020CARM...Biopharmaceuticals, FDA
Protalix BioTherapeutics, Fabry disease, pegunigalsidase alfa