Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of Interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Emma Deeks is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.
Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.
Additional information about this Adis Drug Review can be found here
Odevixibat (Bylvay™) is
a small molecule inhibitor of the ileal bile acid transporter being developed
by Albireo Pharma, Inc. for the treatment of various cholestatic diseases,
including progressive familial intrahepatic cholestasis (PFIC). In July 2021, odevixibat
received its first authorization in the EU for the treatment of PFIC in patients
aged ≥ 6 months, followed
shortly by its approval in the USA for the treatment of pruritus in patients
aged ≥ 3 months with PFIC.
Odevixibat is also in clinical development for the treatment of other
cholestatic diseases, including Alagille syndrome and biliary atresia, in
various countries. This article summarizes the milestones in the development of
odevixibat leading to this first approval for PFIC.
© Springer Nature Switzerland AG 2021