23 October 2023 - Ipsen plans to submit a new marketing authorisation application for the treatment of Alagille syndrome by the end of 2023 under a new brand name.

Ipsen today announced that the EMA's COMP confirmed its negative opinion recommending not to maintain the orphan designation for Bylvay (odevixibat) in Alagille syndrome. This is despite a positive opinion from CHMP in July 2023.

Read Ipsen press release