Albireo Pharma announced in a news release that their phase 3 ASSERT study of odevixibat (Bylvay) in patients with Alagille syndrome (ALGS) is fully enrolled and initial results are expected by the end of the year. They also announced that the commercial launch of odevixibat in the United States, Germany, and the United Kingdom is meeting expectations.

“The global launch of Bylvay continues to go as planned as we generated excellent quarter over quarter growth of patients on Bylvay, mirroring the outstanding reception from [healthcare professionals] and payers,” Ron Cooper, president and chief executive officer of Albireo, said.

“In the upcoming months, we anticipate European launches as we work with country agencies on pricing and reimbursement, while looking ahead to a major Phase 3 readout of the ASSERT study in [ALGS] with the goal of making Bylvay available as quickly as possible to more cholestatic liver patients and families around the globe.”

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The ASSERT trial is a 35-site, double-blind, randomized, placebo-controlled, prospective interventional study assessing the safety and efficacy of odevixibat at a dosage of 120 µg/kg/day over a period of 24 weeks. Patients aged 0 to 17 years who have a genetically confirmed case of ALGS have been enrolled. The primary endpoint is the relief of pruritus, and secondary endpoints include serum bile acid levels, safety, and tolerability.

The company also announced that the total number of reimbursed patients worldwide on odevixibat increased from 53 at the end of 2021 to 87 by the end of the first quarter of 2022. Furthermore, the National Institute for Health and Care Excellence recommended odevixibat for all types of progressive familial intrahepatic cholestasis in patients aged 6 months and above.


Albireo reports Q1 2022 financial results and business update. News release. Albireo Pharma; May 16, 2022.