Tepezza FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 24, 2020.
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 timeline for Tepezza
| Date | Article |
|---|
| Jan 21, 2020 | Approval FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED) |
| Dec 13, 2019 | FDA Advisory Committee Votes Unanimously to Support the Use of Teprotumumab for the Treatment of Thyroid Eye Disease (TED) |
| Oct 31, 2019 | Integrated 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, 2019 | Horizon 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, 2019 | Horizon Therapeutics plc Submits Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED) |
| Apr 26, 2019 | New 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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