Chiesi, Protalix Receive Positive CHMP Opinion For Pegunigalsidase Alfa To Treat Fabry Disease

(RTTNews) - Protalix BioTherapeutics, Inc. (PLX) and Chiesi Global Rare Diseases, a business unit of the Chiesi Group, announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for PRX-102 (pegunigalsidase alfa), the first and only pegylated enzyme for the treatment of adult patients with Fabry disease.

PRX-102 is a novel recombinant human a-Galactosidase-A (a-Gal-A) enzyme being investigated as an enzyme replacement therapy (ERT) for the treatment of Fabry disease.

The positive CHMP opinion was based on a marketing authorization application (MAA) that includes positive data from a comprehensive set of preclinical, clinical and manufacturing studies evaluating PRX-102.

The CHMP opinion is now referred for final action to the European Commission (EC). A final EC decision on the MAA is expected in the beginning of May 2023.