Albireo Ready To Seek Second Bylvay Indication In Alagille Syndrome

Albireo Pharma Inc.’s success for Bylvay (odevixibat) in a Phase III trial in Alagille syndrome means the company is close to filing for regulatory approval, and ready to carry on its head-to-head competition with Mirum Pharmaceuticals, Inc. in the ileal bile acid transporter (IBAT) inhibitor space for cholestatic liver disease.

Albireo reached the market first by a few months in 2021, getting approval of Bylvay for progressive familial intrahepatic cholestasis (PFIC) on 20 July, while Mirum followed in September by obtaining US Food and Drug Administration approval of its IBAT inhibitor Livmarli (maralixibat) for Alagille syndrome. (Also see "Mirum Targets $500m Sales For Just-Approved Rare Liver Disorder Drug" - Scrip, 30 September, 2021