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

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 (CHMP) based on Bylvay Phase III ASSERT clinical-trial data in Alagille syndrome (ALGS) Negative opinion from Committee for Orphan Medicinal Products (COMP) recommending not to maintain orphan drug designation for treatment of ALGS Ipsen to appeal negative COMP opinion…
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