European CHMP recommends approval of odevixibat (Bylvay) for treatment of progressive familial intrahepatic cholestasis (PFIC)

Approval of this reversible, potent, selective inhibitor of the ileal bile acid transporter was via the accelerated assessment programme. The full indication is for treatment of PFIC in pts aged 6 months or older. It will be available as 200 µg, 400 µg, 600 µg & 1200 µg caps.

Source:

European Medicines Agency