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Tepezza Approval History

FDA Approved: Yes (First approved January 21, 2020)
Brand name: Tepezza
Generic name: teprotumumab-trbw
Dosage form: Injection
Company: Horizon Therapeutics plc
Treatment for: Thyroid Eye Disease

Tepezza (teprotumumab-trbw) is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) for the treatment of active thyroid eye disease (TED).

Development History and FDA Approval Process for Tepezza

DateArticle
Jan 21, 2020Approval FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)
Dec 13, 2019FDA Advisory Committee Votes Unanimously to Support the Use of Teprotumumab for the Treatment of Thyroid Eye Disease (TED)
Oct 31, 2019Integrated Clinical Trial Analyses Further Substantiate that Teprotumumab Significantly Improves Debilitating Effects of Thyroid Eye Disease, Including Eye Bulging, Double Vision and Quality of Life
Sep  9, 2019Horizon Therapeutics plc Announces the FDA has Granted Priority Review of the Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED)
Jul 10, 2019Horizon Therapeutics plc Submits Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED)
Apr 26, 2019New Data from Phase 3 Teprotumumab Trial (OPTIC) Shows Dramatic Reduction in Proptosis, or Eye Bulging, the Main Cause of Morbidity in Active Thyroid Eye Disease (TED)

Further information

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