Protalix BioTherapeutics Inc. and Chiesi Global Rare Diseases have requested a re-examination from the European Medicines Agency $(EMA)$ after receiving a negative opinion from the Committee for Medicinal Products for Human Use $(CHMP)$ regarding the proposed alternative dosing regimen of Elfabrio (pegunigalsidase alfa) at 2 mg/kg every four weeks. The currently approved dosing regimen of 1 mg/kg every two weeks remains in effect while the re-examination process is ongoing. The companies remain committed to working with the EMA to address the needs of the Fabry disease community.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Protalix BioTherapeutics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001104659-25-105594), on November 03, 2025, and is solely responsible for the information contained therein.