Benzinga | Jul 19, 2021 09:36AM EDT

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

* The European Commission (EC) has approved Albireo Pharma Inc's (NASDAQ: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.