Protalix Submits Marketing Authorization Application To EMA For PRX-102 For Fabry Disease Treatment

(RTTNews) - Protalix BioTherapeutics Inc. (PLX) and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., announced the submission of a Marketing Authorization Application or MAA via centralized procedure to the European Medicines Agency or EMA for pegunigalsidase alfa (PRX-102) 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, Protalix said in a statement.

Protalix stated that the centralized procedure via the EMA allows for the submission of a single marketing authorization application to the European Union, and, if approved, allows Chiesi, the company's commercial partner, to market and make PRX-102 available to patients and healthcare professionals across the entire European Union.