Posted by Michael Wonder on 14 Feb 2023
FDA grants 15 June 2023 PDUFA date to Albireo for Bylvay in Alagille syndrome
14 February 2023 - ASSERT study demonstrated efficacy of Bylvay in pruritus, bile acids and sleep with a low drug-related diarrhoea rate in Alagille patients.
Albireo Pharma today announced that the US FDA has accepted the Company’s supplemental new drug application and issued a Prescription Drug User Fee Act action date of 15 June 2023 for a second Bylvay (odevixibat) indication for patients with Alagille syndrome.
