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.

Posted In: BriefsLiver DiseaseBiotechNewsHealth CareSmall CapFDAGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.