European Commission approves Protalix's PRX-102 for Fabry disease in EU

Protalix BioTherapeutics, Inc.

EC granted marketing authorization to PRX-102 (pegunigalsidase alfa) for adult Fabry disease patients.
Approval based on clinical program in >140 patients with up to 7.5 years of treatment.
PRX-102 showed non-inferior efficacy to agalsidase beta in controlling kidney disease (eGFR decline).
PRX-102 is not yet approved by FDA; U.S. review ongoing.
Partner Chiesi Global Rare Diseases will commercialize in the EU.

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