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
Newswire & Press Release / Ipsen Updates on E.U. Marketing Authorisation Application for Odevixibat in Alagille Syndrome - Pharma / BioTech / Nutrition - IPSEN Group newswiretoday.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from newswiretoday.com Daily Mail and Mail on Sunday newspapers.
Newswire & Press Release / Ipsen Updates on E.U. Marketing Authorisation Application for Odevixibat in Alagille Syndrome - Pharma / BioTech / Nutrition - IPSEN Group newswiretoday.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from newswiretoday.com Daily Mail and Mail on Sunday newspapers.
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.