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Ipsen updates on E U Marketing Authorisation Application for odevixibat in Alagille syndrome

Positive opinion from Committee for Medicinal Products for Human Use recommending approval of Bylvay® (odevixibat) based on Phase III ASSERT clinical-trial data in Alagille syndrome (ALGS) already received in July 2023Committee for Orphan Medicinal Products confirms a negative opinion of its review recommending not to maintain the orphan designation for Bylvay in ALGSIpsen plans to submit a new Marketing Authorisation Application for the treatment of ALGS by the end of 2023 under a new brand nam

United statesFrance generalUnited kingdomJennifer mooreIoana piscociuChristelle huguetAmy wolfAsia pacificNicolas boglerIpsen euronextHead of corporate brand strategy communicationsCommittee for orphan medicinal productsCommittee for medicinal products humanEuropean society for pediatric gastroenterology hepatologyHead of researchDevelopment for ipsen

Investegate | Company Announcement

Investegate announcements from Ipsen updates on E.U. Marketing Authorisation Application for odevixibat in Alagille syndrome

France generalUnited kingdomUnited statesAsia pacificIpsen euronextChristelle huguetJennifer mooreAmy wolfIoana piscociuNicolas boglerEuropean medicines agencyAlbireo pharma incEuropean society for pediatric gastroenterology hepatologyCommittee for medicinal products humanDevelopment for ipsenHead of research

Newswire & Press Release / Ipsen Updates on E U Marketing Authorisation Application for Odevixibat in Alagille Syndrome - Pharma / BioTech / Nutrition - IPSEN Group

Newswire & Press Release / Ipsen Updates on E U Marketing Authorisation Application for Odevixibat in Alagille Syndrome - Pharma / BioTech / Nutrition - IPSEN Group
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France generalUnited kingdomUnited statesNicolas boglerAsia pacificAmy wolfChristelle huguetIoana piscociuEuropean society for pediatric gastroenterology hepatologyCommittee for orphan medicinal productsHead of researchAgency sourceHead of corporate brand strategy communicationsAlbireo pharma incCommittee for medicinal products human useDevelopment for ipsen

Newswire & Press Release / Ipsen Updates on E U Marketing Authorisation Application for Odevixibat in Alagille Syndrome - Pharma / BioTech / Nutrition - IPSEN Group

France generalUnited statesUnited kingdomIoana piscociuChristelle huguetAmy wolfAsia pacificNicolas boglerHead of researchDevelopment for ipsenCommittee for medicinal products humanEuropean medicines agencyHead of corporate brand strategy communicationsAgency sourceAlbireo pharma incCommittee for medicinal products human use

Correction: Ipsen provides update on E U Marketing Authorization Application for Bylvay® for cholestatic pruritus in patients with Alagille syndrome

Positive opinion from Committee for Medicinal Products for Human Use based on Bylvay Phase III ASSERT clinical-trial data in Alagille syndrome Negative opinion from Committee for Orphan Medicinal.

France generalUnited statesUnited kingdomJennifer mooreIpsen euronextNicolas boglerIoana piscociuHoward mayerAmy wolfAsia pacificDevelopment for ipsenCommittee for medicinal products human useHead of corporate brand strategy communicationsGlobal corporate communicationsEuropean medicines agencyHead of research