Albireo's Bylvay gets FDA green light for PFIC

21 July 2021

July 21, 2021

The US Food & Drug Administration approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC), developed by Boston, USA-based Albireo Pharma (Nasdaq: ALBO), a spinoff of UK-based AstraZeneca (LSE: AZN).

The decision comes a day after the company received European Commission marketing authorization for the drug. Analysts have forecast it could bring in peak annual sales of up to $750 million.

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