ALBO - Albireo's Bylvay OK'd in Europe for rare liver disease in children

Albireo Pharma (ALBO) perks up 2% premarket after announcing European Commission ((EC)) authorization of Bylvay (odevixibat) for the treatment of all subtypes of progressive familial intrahepatic cholestasis ((PFIC)). PFIC is a rare and devastating disorder affecting young children that causes progressive, life-threatening liver disease. The EC authorization was based on data from Phase 3 PEDFIC 1 and PEDFIC 2 trials. Across both studies, Bylvay was well tolerated. Albireo plans to directly commercialize Bylvay in the European Union ((EU)). Germany launch is planned for September 2021. The Company also anticipates an upcoming regulatory decision by the FDA on Bylvay for the treatment of pruritus in patients with PFIC.The FDA has granted a Priority Review for the NDA and has set PDUFA target action date of July 20, 2021.Albireo is also studying Bylvay in other rare pediatric cholestatic diseases with the BOLD Phase 3 trial in patients with biliary atresia and the ASSERT Phase 3 trial in

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Albireo's Bylvay OK'd in Europe for rare liver disease in children