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Albireo Pharma’s Bylvay has received approval on both sides of the Atlantic this week, scoring authorisation in the EU and US for the treatment of all subtypes of progressive familial intrahepatic cholestasis (PFIC).
Albireo Pharma on Tuesday said the FDA cleared Bylvay (odevixibat) to treat moderate-to-severe itching in patients aged three months and older with progressive familial intrahepatic cholestasis (PFIC), making it the first drug approved for all subtypes of
Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC).