FDA Rejects Quick Approval of PRX-102, Plant-based ERT for Adults

FDA Rejects Quick Approval of PRX-102, Plant-based ERT for Adults

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FDA Rejects Quick Approval of PRX-102, Plant-based ERT for Adults

The U.S. Food and Drug Administration (FDA) has rejected Protalix BioTherapeutics and Chiesi Global Rare Diseases’ request for accelerated approval of PRX-102 (pegunigalsidase alfa) as the first plant-based, every-other-week enzyme replacement therapy (ERT) for adults with Fabry disease. “While disappointing, we remain confident in the strength of our data and in the depth of our program,” Dror Bashan, Protalix’s president and CEO, said in a press release. “Based on extensive clinical data including results from the Phase 3 BRIDGE clinical trial of PRX-102…

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