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Protalix Plans US Resubmission For ERT For Fabry After Positive Phase III Trial Results

 
• By Jessica Merrill
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Protalix hopes to resubmit its Fabry drug to FDA • Source: Alamy

Protalix BioTherapeutics, Inc. and partner Chiesi Farmaceutici S.p.A. believe they have the data needed to resubmit the pegylated enzyme replacement therapy (ERT) pegunigalsidase alfa (PRX-102) to the US Food and Drug Administration after receiving a complete response letter last year. The companies announced positive top line results from the Phase III BALANCE trial on 4 April.

The companies believe pegunigalsidase alfa, a plant cell culture-expressed version of the recombinant α-Galactosidase-A enzyme, could offer a superior once-monthly dosing regimen compared to the current ERTs for Fabry disease, Sanofi's Fabrazyme (agalsidase beta) and Takeda Pharmaceutical Co. Ltd.'s Replagal (agalsidase alfa), which are infused every two weeks

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