Protalix Bio launches expanded access program for Fabry Disease med

• Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., and Protalix BioTherapeutics (NYSEMKT:PLX) announce the launch of an Expanded Access Program (EAP) in the U.S. for pegunigalsidase alfa for the proposed treatment of Fabry disease, a rare inherited disorder characterized by the buildup of a type of fat in the body's cells due to the absence or dysfunction of an essential enzyme called alpha-galactosidase A.
• A BLA for pegunigalsidase alfa is currently under review by the FDA. This EAP will run concurrently with Protalix’s ongoing Phase III clinical program.
• Patients participating in the EAP will receive infusions of pegunigalsidase alfa every two weeks at 1mg/kg body weight. Information related to adverse events and other limited data will be collected from participants.
• https://seekingalpha.com/news/3619377-protalix-bio-launches-expanded-access-program-for-pegunigalsidase-alfa-for-fabry-disease-in-u