ALBO - Albireo submits U.S. and European applications for odevixibat in liver disease

Albireo Pharma (ALBO) has submitted a New Drug Application ((NDA)) to the FDA and a Marketing Authorization Application ((MAA)) to the EMA seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis ((PFIC)), a rare disorder that causes progressive, life-threatening liver disease.The EMA has validated the odevixibat MAA on the accelerated assessment timeline, which begins the formal review process. The Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in H2 2021. Odevixibat is a once-daily, non-systemic ileal bile acid transport inhibitor being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome.

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Albireo submits U.S. and European applications for odevixibat in liver disease