Chiesi Global Rare Diseases Seeks Ema Chmp Re-Exam Of Negative View On Elfabrio 2 Mg/Kg Q4w Dosing

Reuters

2025/11/20

Nov 3 (Reuters) - CHIESI GLOBAL RARE DISEASES-:
*CHIESI GLOBAL RARE DISEASES - REQUESTS RE-EXAMINATION OF NEGATIVE OPINION ISSUED BY EMA'S CHMP ON PROPOSED DOSING REGIMEN OF 2 MG/KG EVERY 4 WEEKS FOR ELFABRIO
*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 - EXISTING MARKETING AUTHORIZATION FOR ELFABRIO REMAINS IN EFFECT
*Further company coverage: PBDA.F
* ((Reuters.Briefs@thomsonreuters.com;))

((Reuters Investor Briefs; email: reutersinvestor.briefs@thomsonreuters.com))
Source Date/Time = 03-NOV-202522:14:00.11 GMT

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