VIDEO: Bylvay improves pruritus, reduces serum bile acids in Alagille syndrome
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WASHINGTON D.C. — In a Healio video exclusive, Ron Cooper, CEO of Albireo Pharma, highlighted positive top-line safety and efficacy results of Bylvay for the treatment of Alagille syndrome in patients from birth to early adulthood.
In the double-blind, placebo-controlled phase 3 ASSERT trial, patients were randomized 2:1 to receive once-daily 120 g/kg Bylvay (odevixibat, Albireo), a potent, selective inhibitor of the ileal bile acid transporter, or placebo for 24 weeks. Bylvay was found to be well-tolerated and met its study endpoints of improved pruritus (P = .002) and fatigue as well as reduced serum bile acids (P = .001). Additionally, there were low rates of drug-related diarrhea (11.4% vs. 5.9% in placebo).
“What we have done here with Bylvay is added to our bank of phase 3 trials; now we have two successful phase 3 trials with Bylvay in pediatric cholestasis,” Cooper said. “We are excited that we recently fully enrolled our third phase 3 study in biliary atresia; we eagerly await the results of that study as well.”
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Ovchinsky N, et al. Abstract 5005: Efficacy and safety of odevixibat in patients with Alagille syndrome: Top-line results from ASSERT, a phase 3, double-blind, randomized, placebo-controlled study. Presented at: The Liver Meeting; Nov. 4-8, 2022.
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