25 January 2021 - FDA has granted odevixibat fast track, rare paediatric disease and orphan drug designations.

 Albireo Pharma today announced that the U.S. FDA has accepted the Company’s new drug application for odevixibat for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). 

Odevixibat is a potent, once daily, non-systemic ileal bile acid transport inhibitor being developed to treat patients with rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. 

The FDA has granted priority review and set a Prescription Drug User Fee Act goal date of 20 July 2021, supporting the Company’s previous guidance of a planned launch in the second half of 2021.

Read Albireo Pharma press release