Albireo's Bylvay Scores European Nod For Rare Pediatric Liver Disease

The European Commission (EC) has approved Albireo Pharma Inc's ALBO Bylvay (odevixibat) for all subtypes of progressive familial intrahepatic cholestasis (PFIC).
Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi).
The approval was based on data from PEDFIC 1 and PEDFIC 2 Phase 3 trial.
Bylvay met both its pruritus and serum bile acid primary endpoints and was well-tolerated with a very low incidence of drug-related diarrhea/frequent bowel movements (9.5% of treated patients vs. 5.0% placebo patients).
Albireo plans to commercialize Bylvay in the European Union (EU) directly. This includes Germany, which has the largest EU market potential, with a launch scheduled for September 2021, following price listing.
The Company also anticipates an upcoming regulatory decision by the FDA on Bylvay that is scheduled for tomorrow.
Albireo is also studying the use of 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 Alagille syndrome.
Topline data from the ASSERT trial is expected in 2022, and data from the BOLD trial is scheduled for 2024.
Price Action: ALBO shares are up 4.26% at $36.75 during the market session on the last check Monday.
Related content: Benzinga's Full FDA Calendar.