Chiesi and Protalix announce launch of an EAP for Fabry disease candidate

Family-owned Chiesi Farmaceutici and Israeli biopharma Protalix BioTherapeutics (TASE: PLX) have announced the launch of an expanded access program (EAP) in the USA for pegunigalsidase alfa for the proposed treatment of Fabry disease.

A biologics license application (BLA) for pegunigalsidase alfa is currently under review by the US Food and Drug Administration (FDA). This EAP will run concurrently with Protalix's ongoing Phase III clinical program.

Marcel van Kuijck, global head of medical affairs at Chiesi Global Rare Diseases, said: “The launch of this EAP for pegunigalsidase alfa is another example of Chiesi's and Protalix's shared commitment to support patients whose condition cannot be adequately treated by currently available FDA-approved therapies for Fabry disease.”