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A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)

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Trial Profile

A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2023

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At a glance

  • Drugs Budesonide (Primary)
  • Indications Eosinophilic oesophagitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ORBIT2
  • Sponsors Shire; Takeda

    • Most Recent Events

    • 08 Mar 2023 Results (n=514) assessing the safety of an investigational formulation of budesonide (budesonide oral suspension; BOS) from six trials (SHP621-101 (no clinical trials registration number), MPI 101-01 (NCT00762073), MPI 101-06 (NCT01642212), SHP621-301 (NCT02605837), SHP621-302 (NCT02736409) and SHP621-303 (NCT03245840)), published in the Alimentary Pharmacology and Therapeutics.
    • 21 Dec 2021 According to a Takeda media release, the FDA recommended an additional clinical study in order to help resolve FDA feedback. The company is assessing the details of the CRL and evaluating a regulatory path forward.
    • 21 Dec 2021 According to a Takeda media release, the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for TAK-721 for the treatment of eosinophilic esophagitis (EoE). The CRL indicates the FDA has completed its review and determined that it cannot be approved in its present form.
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