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Chiesi Global Rare Diseases, A Business Unit Of The Chiesi And Protalix Biotherapeutics Announced That The European Medicines Agency Has Validated The Variation Submission For Pegunigalsidase Alfa To Label A Less Frequent Dosing Regimen

Author: Benzinga Newsdesk | December 09, 2024 06:47am

Chiesi Global Rare Diseases, a business unit of the Chiesi and Protalix BioTherapeutics announced that the European Medicines Agency (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.

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