FDA accepts Protalix Fabry disease drug for priority review

The US Food and Drug Administration has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease, says Israel-based Protalix BioTherapeutics (TASE:PLX), whose shares closed up 7.4% at 1,309 shekels on the news.

The drug is being developed and commercialized with Chiesi Global Rare Diseases, a unit of Italian family-controlled Chiesi Farmaceutici, which jointly submitted the BLA in May this year via the FDA's Accelerated Approval pathway.

Pegunigalsidase alfa is the company's purposefully designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate. The FDA set an action date of January 27, 2021, under the Prescription Drug User Fee Act (PDUFA). The FDA also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.