Posted by Michael Wonder on 22 Jul 2023
Ipsen provides update on EU marketing authorisation application for Bylvay for cholestatic pruritus in patients with Alagille syndrome
21 July 2023 - Positive opinion from Committee for Medicinal Products for Human Use (CHMP) based on Bylvay Phase III ASSERT clinical-trial data in Alagille syndrome.
Ipsen (Euronext: IPN: ADR: IPSEY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Bylvay® (odevixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged six months or older.
