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A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT)

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Trial Profile

A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2024

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At a glance

  • Drugs Odevixibat (Primary)
  • Indications Alagille syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms ASSERT
  • Sponsors Albireo Pharma

Most Recent Events

  • 23 Sep 2024 According to an Ipsen media release, full results of this study have been published in the Lancet, Gastroenterology & Hepatology in April 2024.
  • 23 Sep 2024 According to an Ipsen media release, the European Commission has approved Kayfanda (odevixibat) under exceptional circumstances for the treatment of cholestatic pruritus in Alagille Syndrome (ALGS) in patients aged 6 months or older, based on the data from this study.
  • 26 Jul 2024 According to an Ipsen media release, company announced today positive opinion by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) for rare cholestatic liver disease (Alagille syndrome) medicines. The European Commission will now consider the CHMP recommendations. Final decisions on marketing authorization for Kayfanda is anticipated in Q3, 2024.

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