|Other names||Teprotumumab-trbw, RG-1507|
|Drug class||Monoclonal antibody|
|Main uses||Thyroid eye disease (TED)|
|Side effects||Muscle spasm, nausea, hair loss, diarrhea, fatigue, high blood sugar, hearing loss, dry skin, altered taste, headache|
|Chemical and physical data|
|Molar mass||145639.97 g·mol−1|
Common side effects include muscle spasm, nausea, hair loss, diarrhea, fatigue, high blood sugar, hearing loss, dry skin, altered taste, and headache. Other side effects may include Infusion reactions. It should not be used during or for the six months prior to pregnant. It is a human monoclonal antibody which binds to insulin-like growth factor-1 receptor (IGF-1R) thereby preventing its activation.
In Graves' ophthalmopathy teprotumumab was more effective than placebo. 82.9 percent of teprotumumab patients compared to 9.5 percent of placebo patients improved 2 mm or more reduction in proptosis. All secondary endpoints were also met and the safety profile was consistent with the Phase II study of teprotumumab in TED.
It is generally give as 8 doses with the first of 10 mg/kg followed every three weeks at a dose of 20 mg/kg.
On 10 July 2019, Horizon submitted a Biologics License Application (BLA) to the FDA for teprotumumab for the treatment of active thyroid eye disease (TED). Horizon requested priority review for the application - if so granted (FDA has a 60-day review period to decide) it would result in a max. 6 month review process.
Teprotumumab was first investigated for the treatment of solid and hematologic tumors, including breast cancer, Hodgkin's and non-Hodgkin's lymphoma, non-small cell lung cancer and sarcoma. Although results of Phase I and early Phase II trials showed promise, research for these indications were discontinued in 2009, by Roche. Phase II trials still in progress were allowed to complete, as the development was halted due to business prioritization rather than safety concerns.
Teprotumumab was subsequently licensed to River Vision Development Corporation in 2012, for research in the treatment of ophthalmic conditions. Horizon Pharma (now Horizon Therapeutics, from hereon Horizon) acquired RVDC in 2017, and will continue clinical trials. It is in Phase III trials for Graves' ophthalmopathy (also known as thyroid eye disease (TED)) and Phase I for diabetic macular edema. It was granted Breakthrough Therapy, Orphan Drug Status and Fast Track designations by the FDA for Graves' ophthalmopathy.
Teprotumumab-trbw was approved based on the results of two clinical trials (Trial 1/ NCT01868997 and Trial 2/ NCT03298867) of 170 subjects with active thyroid eye disease who were randomized to either receive teprotumumab-trbw or a placebo. Of the subjects who were administered Tepezza, 71% in Study 1 and 83% in Study 2 demonstrated a greater than two millimeter reduction in proptosis (eye protrusion) as compared to 20% and 10% of subjects who received placebo, respectively. The trials were conducted at 28 sites in Europe and United States.
The U.S. Food and Drug Administration (FDA) granted the application for teprotumumab-trbw fast track designation, breakthrough therapy designation, priority review designation, and orphan drug designation. The FDA granted the approval of Tepezza to Horizon Therapeutics Ireland DAC.
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