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October 23, 2023
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 bran...
October 23, 2023
Investegate announcements from Ipsen updates on E.U. Marketing Authorisation Application for odevixibat in Alagille syndrome
July 21, 2023
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...
July 21, 2023
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...
July 19, 2023
European Commission determines not to grant marketing authorization approval for palovarotene for fibrodysplasia ossificans progressiva Decision follows negative opinion by the Committee for Medicinal...
July 19, 2023
European Commission determines not to grant marketing authorization approval for palovarotene for fibrodysplasia ossificans progressiva (FOP)Decision...
June 30, 2023
Trial met primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to placeboElafibranor was well tolerated with a safety profile
June 29, 2023
Advisory committee voted 10 for and 4 against that evidence from the Phase III MOVE study show palovarotene is an effective treatment in patients with the...
June 29, 2023
An FDA committee voted favorably on whether the available evidence supports the effectiveness of palovarotene for fibrodysplasia ossificans progressiva.
June 13, 2023
Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related pruritus in 2021 Immediate U.S. commercial... | June 13, 2023