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

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

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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 Type A meeting,” Dror Bashan, Protalix’s president and CEO, said in a press release. “We remain committed to the Fabry community and our goal of providing an alternative…

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