预约演示
EC grants marketing approval for Chiesi, Protalix’s Fabry disease therapy
2023-05-08
上市批准
PRX-102 is indicated for the treatment of Fabry disease in adult patients. Credit: Pr Marie-Claire GUBLER, Paris, France / commons.wikimedia.org.
PRX-102opean Commission (EC) has granted mFabry diseaseorisation to Chiesi Global Rare Diseases and Protalix BioTherapeutics’ PRX-102 (pegunigalsidase alfa) in the European Union (EU) to treat Fabry disease in adult patients.
The PEGylated enzyme replacement therapy (ERT), PRX-102 is a plant cell culture-expressed, and chemiProtalix BioTherapeuticsntPRX-102n pegunigalsidase alfase‑A enzyme.Fabry disease
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It was found to have a favourable circulatory half-life of about 80 hours, with targeted enzyme activity in organs that are affected by Fabry disease, in clinical trials.
Chiesi Global Rare Diseases Naratuximab Emtansineaid:Follicular Lymphomah Fabry disease often perceive their disease as burdensome and still experience unmet medical needs.
“Our deepest gratitude to all patients and patient advocates who have stood shoulder-to-shoulder with clinical researchers, scientists, and regulators during the clinical development programme, providing the data needed for this approval.”
The authorisation from EC was based on the data obtained from a comprehensive clinical development programme, which was conducted in oveFabry diseases, who received treatment for up to 7.5 years.
The company stated that PRX-102 has been investigated in ERT-experienced aFabry diseasepatients, including in a head-to-head trial.
It showed non-inferior efficacy to agalsidase beta in controlling the kidney disease, as assessed by the estimated glomerular filtration rate (eGFR) decline.
Protalix BioTherapeutics president and CEO Dror Bashan said: “The European Commission’s approval of PRX-102 is a significant milestone for patients with Fabry disease and their families, providing a new therapeutic option.
“Based on solid results PRX-102r robust clinical programmes, PRX-102 has the potential to be widely used for many years to come.”
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