PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Tex18]

Protalix Bio says FDA rejection for PRX–102 was not due to safety/ efficacy issues
Apr. 28, 2021 2:29 PM ETProtalix BioTherapeutics, Inc. (PLX)
By: Dulan Lokuwithana, SA News Editor

Giving further updates on the FDA rejection of its experimental therapy pegunigalsidase alfa (PRX–102) for Fabry disease, Protalix BioTherapeutics (PLX -37.6%) says that the regulator has not cited any safety or efficacy concerns in the Complete Response Letter ("CRL").

The inspection of the company’s Protalix's manufacturing facility in Carmiel, Israel was required for the approval of the marketing application along with a subsequent assessment of findings, the FDA has said.
But the regulator was unable to inspect the site on time due to COVID-related restrictions on travel.

As for the third-party fill and finish facility in Europe for PRX-102, the FDA has said it will communicate any outstanding issues to the manufacturer.

The regulator has also highlighted the full approval granted for Fabrazyme, a development Protalix will have to consider in any resubmission of the accelerated approval for PRX–102.

The company is planning to request a Type-A meeting with the FDA.

PRX–102 achieved study outcome in the BRIGHT study which involved 30 patients with Fabry disease previously treated with enzyme replacement therapy (NASDAQ:ERT) (agalsidase alfa – Replagal or agalsidase beta – Fabrazyme).