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A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Trial Evaluating HZN-001 (teprotumumab) Treatment in Japanese Patients with Active Thyroid Eye Disease

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Trial Profile

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Trial Evaluating HZN-001 (teprotumumab) Treatment in Japanese Patients with Active Thyroid Eye Disease

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Feb 2025

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At a glance

  • Drugs Teprotumumab (Primary)
  • Indications Graves ophthalmopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIC-J
  • Sponsors Horizon Therapeutics plc

    • Most Recent Events

    • 04 Feb 2025 According to an Amgen media release, regulatory review is underway in multiple additional geographies including with the European Medicines Agency (EMA) where approval is anticipated in H2 2025.
    • 24 Sep 2024 According to Amgen media release, TEPEZZA received orphan drug designation in Japan, which provided a nine-month regulatory review period compared to the standard 12-month review. The approval was based on the positive results of OPTIC-J trial.
    • 26 Apr 2024 According to an Amgen media release, the company announced the imminent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for teprotumumab, for the treatment of moderate to severe Thyroid Eye Disease (TED) in adults. The MAA is supported by clinical studies NCT01868997, NCT03298867, NCT04583735, and, jRCT2031210453.

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