Chiesi, Protalix: Positive CHMP Opinion for Pegunigalsidase Alfa for Treatment of Fabry Disease

 European Commission decision anticipated in beginning of May 2023 -

Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix Biotherapeutics, Inc.,  (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company, announced today 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.

https://www.biospace.com/article/releases/chiesi-global-rare-diseases-and-protalix-biotherapeutics-receive-positive-chmp-opinion-for-pegunigalsidase-alfa-for-treatment-of-fabry-disease/