FDA Grants June 15, 2023 PDUFA Date to Albireo for Bylvay® in Alagille Syndrome

 

• Bylvay (odevixibat)granted Priority Review by U.S. FDA
   
• ASSERT study demonstrated efficacy of Bylvay in pruritus, bile acids and sleep with a low drug-related diarrhea rate in Alagille patients
   
• Approval in second indication would more than double Bylvay market opportunity

https://www.biospace.com/article/releases/fda-grants-june-15-2023-pdufa-date-to-albireo-for-bylvay-in-alagille-syndrome/