Elfabrio's E4W approval differentiates PLX in Fabry disease, but sustainable revenue growth hinges on converting the dosing advantage into durable market share gains

Protalix BioTherapeutics is a commercial-stage company with an approved enzyme replacement therapy for Fabry disease, a rare inherited metabolic disorder, that stands as the only such treatment in the EU and UK dosed once every four weeks.

Elfabrio (pegunigalsidase alfa) is an approved enzyme replacement therapy for Fabry disease, now the only ERT in the EU and UK with a once-every-four-weeks dosing label. The thesis resolves on whether the E4W dosing advantage translates into measurable patient and prescriber switching away from Sanofi's Fabrazyme and Takeda's Replagal. Gene therapy entrants — notably uniQure's AMT-191 in development — represent the structural long-term threat to the entire ERT class.