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Chiesi Global Rare Diseases and Protalix BioTherapeutics Seek Re-examination from the EMA for the Negative Opinion for Elfabrio (pegunigalsidase alfa) Alternative Dosing Regimen of Every Four Weeks in the EU

-- Every two weeks remains approved as a dosing regimen of Elfabrio in the EU --PARMA, Italy and CARMIEL, Israel, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), have requested a re-examination of the recent negative opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the proposed dosing regimen of 2 mg/kg body weigh

articleProtalix Biotherapeutics, Inc. (de)November 3, 20258/company/protalix-biotherapeutics-inc-de/news/chiesi-global-rare-diseases-and-protalix-biotherapeutics-seek-re-examination-from-the-ema-for-the-negative-opinion-for-elfabrio-pegunigalsidase-alfa-alternative-dosing-regimen-of-every-four-weeks-in-the-eu
Chiesi Global Rare Diseases and Protalix BioTherapeutics Seek Re-examination from the EMA for the Negative Opinion for Elfabrio (pegunigalsidase alfa) Alternative Dosing Regimen of Every Four Weeks in the EU

About this update from Protalix Biotherapeutics, Inc. (de)

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More updates from Protalix Biotherapeutics, Inc. (de)

Protalix BioTherapeuticsChiesi GroupRare DiseasesHYPERSENSITIVITY REACTIONSFabry diseaseEuropean Medicines Agencyclinical trialsmedical treatmentChiesisigns and symptoms