Protalix Asks FDA to Discuss Future of PRX-102

Protalix Asks FDA to Discuss Future of PRX-102

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Protalix Asks FDA to Discuss Future of PRX-102

Protalix BioTherapeutics has requested a type A meeting with the U.S. Food and Drug Administration (FDA) to discuss a path forward for approval of PRX-102 (pegunigalsidase alfa), an investigational therapy for Fabry disease that was rejected by the regulatory agency earlier this year. The meeting is expected to take place within 30 days of the FDA’s receipt of the request, according to a press release from Protalix dated Aug. 2. A plant-based enzyme replacement therapy,…

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