Author Archives: Steve Bryson PhD

FDA Meeting Likely to Lead to New Request for PRX-102 Approval

A recent type A meeting with the U.S. Food and Drug Administration (FDA) is likely to lead Protalix Biotherapeutics to resubmit a request for approval of PRX-102 (pegunigalsidase alfa) to treat Fabry disease, after its initial application was rejected by the agency. “We are pleased with the results of the…

Fabry Identified in Central Asian Family for First Time

Two cases of Fabry disease, diagnosed decades after symptom onset, were identified for the first time in a Central Asian family, a case study reported. Further analysis revealed many affected family members, demonstrating the importance of examining the relatives of people diagnosed with Fabry, the…

Fabrazyme Safe, Effective in Japanese Study

Fabrazyme (agalsidase beta) demonstrated an acceptable safety profile and resulted in sustained reductions in globotriaosylceramide (GL-3) levels over seven years among patients with Fabry disease, a large real-world study from in Japan found.  The study, “…