Protalix, Chiesi announce EMA validation of pegunigalsidase Variation Submission

Chiesi Global Rare Diseases and Protalix (PLX) announced that the European Medicines Agency, or EMA, has validated the Variation Submission for pegunigalsidase alfa to label a less frequent dosing regimen at a dose of 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease. The currently approved dose of pegunigalsidase alfa is 1 mg/kg administered every two weeks. The variation application is supported by a revised Population-PK model and new exposure-response analyses and by the clinical data on pegunigalsidase alfa 2 mg/kg E4W from the completed Phase 3 study PB-102-F50 and its ongoing extension study CLI-06657AA1-03, that have investigated the 2 mg/kg every four weeks dosing regimen in adult patients with Fabry disease who were previously treated with agalsidase-alfa or -beta administered every two weeks. Results of the completed study PB-102-F50 were recently published in the Journal of Inherited Metabolic Disease.