Albireo Dashes Into PFIC Market As FDA, EMA Approve Bylvay

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.

The Boston-based company said 20 July that it received FDA approval for Bylvay for pruritis in all subtypes of PFIC, a form of pediatric cholestatic liver disease, a day after the European Commission approved the drug