Ipsen has received approval from the US Food and Drug Administration (FDA) for Bylvay, a drug used to treat cholestatic pruritus in patients with Alagille syndrome aged 12 months or older. This marks the second rare cholestatic liver disease indication for Bylvay in the US after progressive familial intrahepatic cholestasis related pruritus in 2021. The approval was based on positive data from the Phase III ASSERT study, which showed highly statistically significant and clinically meaningful sustained improvements in pruritus, as well as improvement in certain sleep disturbances and reduction in bile acids, with a low drug-related diarrhea rate in patients with Alagille syndrome. Bylvay is immediately available via prescription for eligible ALGS patients. The Committee for Medicinal Products for Human Use opinion is expected to be given by Q2 2023 with final European Medicines Agency decision anticipated in H2 2023.
Keywords: Ipsen, FDA, Bylvay, Alagille syndrome, cholestatic pruritus
Bylvay has been approved by the US FDA for use in treating cholestatic pruritus caused by Alagille syndrome. This marks the second rare cholestatic liver disease indication for Bylv