Enrollment completed for pivotal phase 3 study of odevixibat in ALGS
Patient enrollment in the ASSERT study, a phase 3 pivotal trial of odevixibat (Bylvay; Albireo) in patients with Alagille syndrome (ALGS) has been completed, according to a press release. Topline results are expected to be available by the end of the year.
Odevixibat is a once-daily, non-systemic ileal bile acid transport inhibitor (IBATi). It is already approved in the US for the treatment of pruritus in patients ≥ 3 months of age in all types of Progressive familial intrahepatic cholestasis.
ASSERT is a gold standard, global, double-blind, randomized, placebo-controlled trial designed to evaluate the safety and efficacy of odevixibat in patients with ALGS over 24 weeks.
According to the press release, the United States Food and Drug Administration agreed on the study design and indicated that the single study would be sufficient for regulatory filings.
Read the full press release here.
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