Albireo Dashes Into PFIC Market As FDA, EMA Approve Bylvay

The company anticipates an addressable global market for progressive familial intrahepatic cholestasis of 2,500 patients, with initial plans to focus on around 100 physicians at 60 centers.

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Albireo is aiming to launch Bylvay immediately in the US, targeting around 100 physicians at 60 centers • Source: Shutterstock

Albireo Pharma Inc. anticipates a rapid launch of Bylvay (odevixibat) after it received back-to-back approvals from the US Food and Drug Administration and European Medicines Agency for progressive familial intrahepatic cholestasis (PFIC), with reimbursement expected to come through over the course of the second half of the year in the US and Europe.

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