Protalix Resubmits To FDA The BLA For Pegunigalsidase Alfa For Treatment Of Fabry Disease
(RTTNews) - Biopharmaceutical company Protalix BioTherapeutics, Inc. (PLX) announced Monday the resubmission on Wednesday of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease.
Pegunigalsidase alfa is a purposefully-designed, long-acting recombinant, PEGylated, cross-linked a-galactosidase-A investigational product candidate.
The BLA resubmission includes a comprehensive set of clinical and manufacturing data, which was compiled from studies that involved more than 140 Fabry disease patients with up to five years of follow up including all three completed studies in the PRX-102 Phase III clinical program.
The BLA resubmission also includes safety data compiled from the ongoing phase III extension studies of PRX-102. If approved, Protalix will be eligible to receive a milestone payment from Italian pharmaceutical company Chiesi Farmaceutici S.p.A. upon BLA approval.
Protalix and Chiesi anticipate that the FDA will complete its review of the resubmission within six months of receipt.
The European Medicines Agency (EMA) is currently reviewing the marketing authorization application for PRX-102, and interactions with the EMA are ongoing.
For More Such Health News, visit rttnews.com
Protalix BioTherapeutics Appoints Eliot Richard Forster To Succeed Zeev Bronfeld As Chairman
Chiesi, Protalix Receive Positive CHMP Opinion For Pegunigalsidase Alfa To Treat Fabry Disease
Indonesia Shares Poised To End Losing Streak
Japanese Market Slightly Higher
Higher Open Anticipated For Hong Kong Shares
Australian Market Slightly Higher
China Shares Tipped To Open In The Green
