Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related pruritus in 2021 Immediate U.S. commercial. | June 13, 2023
Odevixibat is indicated for treatment of cholestatic pruritus associated with Alagille syndrome in patients as young as 12 months. It marks the second indication for the drug.
Ipsen Pharma: U S FDA approves Bylvay® for patients living with cholestatic pruritus due to Alagille syndrome finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.
The approval makes odevixibat the second IBAT inhibitor approved for the rare genetic disease, with capability to benefit both liver damage and itch symptoms.
The FDA has approved Bylvay for the treatment of cholestatic pruritus due to Alagille syndrome in patients aged 12 months or older, according to an Ipsen Biopharmaceuticals press release.This approval marks the second rare cholestatic liver disease indication for Bylvay (odevixibat, Ipsen/Albiero Pharmaceuticals), a non-systemic ileal bile acid transport inhibitor originally approved in 2021 for