U.S. FDA approves Bylvay® for patients living with cholestatic pruritus due to Alagille syndrome
Bylvay was approved as the first drug treatment option for patients living with cholestatic pruritus due to progressive familial intrahepatic cholestasis (PFIC) in the U.S., and for the treatment of PFIC in Europe, in 2021.
- Bylvay was approved as the first drug treatment option for patients living with cholestatic pruritus due to progressive familial intrahepatic cholestasis (PFIC) in the U.S., and for the treatment of PFIC in Europe, in 2021.
- More than 90% of patients were pruritus responders (≥ 1 point change at any time during 24 weeks).
- No patients discontinued the study and 96% of patients rolled over into the open-label extension study.
- In a third indication, the rare pediatric cholestatic liver disease, biliary atresia, Bylvay is in late-stage development with the Phase III BOLD trial.