FDA accepts Protalix application for enzyme replacement therapy for Fabry

Under Priority Review status, the FDA accepts for review Protalix BioTherapeutics’ (NYSEMKT:PLX) marketing application seeking approval of enzyme replacement therapy pegunigalsidase alfa for the treatment of adults with Fabry disease, an inherited disorder characterized by the buildup of a type of fat in the body’s cells due to the absence or dysfunction in a particular enzyme.

The agency’s action date is January 27, 2021.

https://seekingalpha.com/news/3603925-fda-accepts-protalix-application-for-enzyme-replacement-therapy-for-fabry