Chiesi, Protalix receive positive CHMP opinion for Elfabrio dosing regimen.

Chiesi Global Rare Diseases and Protalix BioTherapeutics have received a positive opinion from the EU's CHMP for an additional dosing regimen of Elfabrio (pegunigalsidase alfa) every four weeks. If approved by the European Commission, this dosing regimen would reduce the treatment burden for patients, their families, and the healthcare system. The new dosing regimen is not approved in the US, where the current approved dosing regimen remains 1 mg/kg every two weeks.