Albireo files for FDA and EMA approval of odevixibat for PFIC

Boston, USA-based biotech Albireo Pharma (Nasdaq: ALBO) has submitted a New Drug Application (NDA) to the US Food and Drug Administration and a Marketing Authorization Application (MAA) to the European Medicines Agency seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC).

News of the filings saw Albireo’s share close up 2.8% on Tuesday and edge up a further 1.5% to $41.55 in pre-market trading today.

Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. The EMA has validated the odevixibat MAA on the accelerated assessment timeline, which begins the formal review process. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for patients with PFIC in the USA and Europe, the company noted.