Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive EMA’s CHMP Positive Opinion of Pegunigalsidase Alfa for Fabry Disease
- The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for PRX–102 to treat adult patients with Fabry disease. The EC’s final decision on the MAA is expected in May 2023
- The opinion was based on positive data from a comprehensive set of preclinical, clinical & manufacturing studies & clinical programs incl. P-III (BALANCE), (BRIDGE) & (BRIGHT) trials, the P-I/II trial, and ongoing related extension studies. The tolerability & immunogenicity profiles of PRX-102, acc. to data from the clinical program suggested that it has the potential to be a long-lasting therapy
- PRX–102 is a novel recombinant human α–Gal–A enzyme that is being investigated as an enzyme replacement therapy (ERT) for Fabry disease
Ref: PRNewswire | Image: Protalix BioTherapeutics
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