Posted by Michael Wonder on 25 Feb 2022
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce the submission of a marketing authorisation application to the European Medicines Agency for PRX-102 for the treatment of Fabry disease
24 February 2022 - Protalix BioTherapeutics and Chiesi Global Rare Diseases today announced the submission of a marketing authorisation application via centralised procedure to the EMA for pegunigalsidase alfa (PRX–102) for the proposed treatment of adults with Fabry disease, and the subsequent validation of the marketing authorisation application by the EMA.
The marketing authorisation application submission includes a comprehensive set of pre-clinical, clinical and manufacturing data compiled from the Company's completed and ongoing clinical studies evaluating PRX–102 as a potential treatment for Fabry disease.
