PRX 102 filed with EMA for Fabry disease.
Protalix BioTherapeutics and Chiesi Global Rare Diseases announced the submission of a Marketing Authorization Application (MAA) via centralized procedure to the European Medicines Agency (EMA) for PRX 102 (pegunigalsidase alfa) for the proposed treatment of adults with Fabry disease, and the subsequent validation of the MAA by the EMA.
The MAA submission includes a comprehensive set of preclinical, clinical and manufacturing data compiled from the Company's completed and ongoing clinical studies evaluating PRX 102 as a potential treatment for Fabry disease. The submission is supported by the 12–month interim data analysis generated from the phase III BALANCE clinical trial, which was released in June 2021. Data generated from the completed phase III BRIDGE clinical trial, the phase I/II clinical trial in naive or untreated patients, and from the related extension studies with 1 mg/kg every two weeks were also included in the filing. In addition, the MAA includes data from the completed 12–month switch–over phase III BRIGHT clinical trial of patients treated with the 2 mg/kg every 4 weeks dosage.
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