Author Archives: Patricia Inacio PhD

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…

Protalix BioTherapeutics Completes Enrollment for PRX-102 Phase 3 Trial  

Protalix BioTherapeutics announced it has completed enrollment of its Phase 3 trial evaluating PRX-102 in Fabry disease patients previously treated with Shire’s Replagal (agalsidase alfa). The BRIDGE trial (NCT03018730) is an open-label switch-over study that will assess the safety and efficacy of PRX-102 in 22 patients with Fabry disease treated with Replagal for…

Diagnostic, Treatment Options for Fabry Disease Summarized in Review

A recent review has summarized the current diagnostic tools and available treatments for Fabry disease,  highlighting the challenges and potential new avenues to improve patients’ diagnoses and clinical outcomes. The review, “Diagnosis and Treatment of the Cardiovascular Consequences of Fabry Disease” was published in the QJM: An International…