FDA extends PDUFA for Pegunigalsidase alfa (PRX–102) in Fabry disease

Pegunigalsidase alfa (PRX–102) update : Protalix BioTherapeutics said that the US Food and Drug Administration (FDA) has extended the prescription drug user fee act (PDUFA) date for review of pegunigalsidase alfa (PRX–102) as a treatment of adults with Fabry disease.

The PDUFA action date for reviewing the company’s biologics license application (BLA) has been extended by the FDA by three months to 27 April 2021 from 27 January 2021.

The US drug regulator accepted the BLA, and gave priority review designation to pegunigalsidase alfa (PRX–102) under its accelerated approval pathway.

According to the Israeli pharma company, the FDA indicated that it is currently not intending to have an advisory committee meeting to discuss the BLA.

The BLA submission for pegunigalsidase alfa (PRX–102) contains preclinical, clinical, and manufacturing data compiled from a completed phase I/II clinical trial. These include the related extension study carried out after the phase I/II clinical trial, interim clinical data compiled from the phase 3 BRIDGE switch-over study and safety data from ongoing clinical studies of PRX–102 in patients who were given one mg/kg every other week.

Pegunigalsidase alfa (PRX–102) is a plant cell culture-expressed, chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme.

Protalix BioTherapeutics has joined forces with Chiesi Global Rare Diseases, both in the US and outside the US, for the development and commercialization of pegunigalsidase alfa.