EU approves PRX 102 for Fabry Disease.- Chiesi and Protalix BioTherapeutics
Chiesi Group and Protalix BioTherapeutics announced that the European Commission has granted marketing authorization to PRX 102 (pegunigalsidase alfa) in the European Union for the treatment of adult patients with Fabry disease.
The EC authorization of PRX-102 is based on results from a comprehensive clinical development program in more than 140 patients with up to 7.5 years of treatment. It has been studied in both ERT-naïve and ERT-experienced patients, including a head-to-head trial that met its primary endpoint, with PRX-102 demonstrating non-inferior efficacy to agalsidase beta in controlling kidney disease as evaluated by the estimated glomerular filtration rate (eGFR) decline.
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