Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive EC’s Marketing Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease
Shots:
- The EC has granted marketing authorization to PRX-102 (pegunigalsidase alfa) in the EU for the treatment of adult patients with Fabry disease
- The EC authorization was based on the results from a comprehensive clinical development program in +140 ERT-naïve and ERT-experienced patients with ~7.5yrs. of treatment, incl. a head-to-head trial that met its 1EPs & showed non-inferior efficacy to agalsidase beta in controlling kidney disease as evaluated by eGFR decline
- PRX–102, a PEGylated enzyme replacement therapy (ERT) has been shown to have a circulatory half-life of ~80hrs. in clinical studies. The therapy is currently under the US FDA's review
Ref: Protalix | Image: PR Newswire
Related News:- Protalix BioTherapeutics and Chiesi Report Results of PRX-102 in P-III (BALANCE) Trial for the Treatment of Fabry Disease
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