FDA approves Bylvay for patients living with cholestatic pruritus due to Alagille syndrome – Ipsen

Ipsen announced that the FDA has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome (ALGS). Bylvay is a once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) that acts locally in the small intestine and has minimal systemic exposure. Bylvay was approved as the first drug treatment option for patients […]

MHRA approves Bylvay for progressive familial intrahepatic cholestasis – Albireo Pharma

Albireo Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Bylvay (odevixibat) for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC). The MHRA authorization follows the European Commission (EC) authorization of Bylvay in July 2021. The MHRA authorization was based on data from PEDFIC 1 and PEDFIC 2, the […]