Chiesi, Protalix seek EU EMA re-examination of Elfabrio negative opinion.

Chiesi Global Rare Diseases and Protalix BioTherapeutics have requested a re-examination of the EMA's negative opinion on a proposed dosing regimen for Elfabrio (pegunigalsidase alfa) in the EU. The proposed dosing regimen of every four weeks was rejected, but the every two weeks regimen remains approved. The re-examination request aims to reconsider the proposed dosing regimen.