Chiesi Global, Protalix Announce EMA Validation Of Variation Submission For Pegunigalsidase Alfa

(RTTNews) - Chiesi Global Rare Diseases, a unit of Chiesi Group, and Protalix BioTherapeutics announced the European Medicines Agency 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.

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