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A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA in Treating Patients With Chronic (Inactive) Thyroid Eye Disease

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Trial Profile

A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA in Treating Patients With Chronic (Inactive) Thyroid Eye Disease

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 29 May 2025

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At a glance

  • Drugs Teprotumumab (Primary)
  • Indications Graves ophthalmopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms Chronic TED Trial
  • Sponsors Horizon Pharma USA

Most Recent Events

  • 07 May 2025 According to an Amgen media release, based on the data from this study and other studies (TED01RV Phase 2 study, HZNP-TEP-403 Phase 4 study, OPTIC-J Phase 3 study) UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for TEPEZZA (teprotumumab) as the first therapy specifically licensed for the treatment of adult patients with moderate-to-severe Thyroid Eye Disease (TED).
  • 25 Apr 2025 According to a European Medicines Agency media release, based on the data from this study, EMA has recommended granting a marketing authorisation in the European Union (EU) for Tepezza (teprotumumab), for the treatment of adults with moderate to severe thyroid eye disease.
  • 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.

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