Protalix BioTherapeutics Unit Requests Reexamination Of Negative Opinion Issued By CHMP Related To Proposed Dosing Regimen Of 2 Mg/kg Body Weight Infused Every 4 Weeks For Elfabrio

Chiesi Global Rare Diseases, a business unit of the Chiesi Group, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), have requested a re-examination of the recent negative opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the proposed dosing regimen of 2 mg/kg body weight infused every 4 weeks (E4W) for Elfabrio® (pegunigalsidase alfa).

The opinion concerns the request to add the E4W dosing regimen to the currently approved 1 mg/kg every 2 weeks (E2W) regimen. The existing marketing authorization for Elfabrio remains in effect pending the outcome of the re-examination procedure and subsequent decision by the European Commission (EC).

Both Chiesi and Protalix remain fully committed to working closely with the EMA through the re-examination process and to addressing the high unmet medical needs of the Fabry community.