Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for Pegunigalsidase Alfa for Treatment of Fabry Disease.
Chiesi and their partners at Protalix are deeply committed to people living with Fabry disease and their families, many of whom experience unmet medical needs,” said Giacomo Chiesi, Head of Chiesi Global Rare Diseases. “Our deepest gratitude to all the individuals with Fabry disease who have participated in clinical trials. Thanks to them, PRX‑102 has been extensively studied during the clinical development program, providing the data for the CHMP’s evaluation and positive opinion regarding a positive benefit-risk profile for PRX‑102. They look forward to advancing towards approval and launch in Europe and will continue their mission to deliver this potential new treatment option to people living with Fabry disease around the world.