Author Archives: Patricia Inacio PhD

PRX-102 Given to 1st Patient in US Under Expanded Access Program

A first patient has been treated with PRX-102 (pegunigalsidase alfa), an investigational enzyme replacement therapy for Fabry disease that is under review for approval, through an expanded access program (EAP) in the United States. “The initiation of treatment in the first patient enrolled in our EAP is an important milestone for the Fabry…

Protalix and Chiesi Get FDA OK to Seek Accelerated Approval of PRX-102 for Fabry Disease

PRX-102 (pegunigalsidase alfa), an investigational enzyme replacement therapy (ERT) for Fabry disease, is closer to accelerated approval after a successful pre-biologics license application (BLA) meeting with the U.S. Food and Drug Administration (FDA), according to a press release. PRX-102’s developers, Protalix BioTherapeutics and Chiesi Farmaceutici, met with…

Fabry Disease Unlikely to be Misdiagnosed for RA in Clinical Practice, Study Suggests

Fabry disease shares some manifestations with rheumatic diseases, which has raised concerns of wrongful diagnosis and consequent delayed treatment. Still, patients with this rare genetic disease are unlikely to be systematically overlooked in clinical rheumatology practice, results of a genetic analysis of German patients with early undifferentiated arthritis shows. The…