Teprotumumab: First Approval

Overview

Journal Drugs

Specialty Pharmacology

Date 2020 Mar 12

PMID 32157641

Citations 24

Authors

Anthony Markham

Affiliations

Soon will be listed here.

Abstract

Teprotumumab (teprotumumab-trbw; TEPEZZA™ - Horizon Therapeutics) is a monoclonal antibody insulin-like growth factor-I receptor (IGF-IR) antagonist developed for the treatment of thyroid eye disease (Graves ophthalmopathy/orbitopathy, thyroid-associated ophthalmopathy). Based on positive results from two multinational clinical trials teprotumumab was recently approved for this indication in the US. This article summarizes the milestones in the development of teprotumumab leading to this first approval for thyroid eye disease.

Citing Articles

Teprotumumab for thyroid eye disease in patients with hypothyroid/euthyroid state: a multicenter case series.

Ugradar S, Parunakian E, Malkhasyan E, Raika P, Tolentino J, Kossler A Graefes Arch Clin Exp Ophthalmol. 2024; 263(1):225-230.

PMID: 39136754 DOI: 10.1007/s00417-024-06599-3.

Postmarketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment.

Huang J, Su A, Yang J, Zhuang W, Li Sr Z J Clin Endocrinol Metab. 2024; 110(1):159-165.

PMID: 38878281 PMC: 11651674. DOI: 10.1210/clinem/dgae417.

Side Effects and Adverse Events After Treatment With Teprotumumab for Thyroid Eye Disease: A Retrospective Observational Case Series.

Mukit F, Manley A, Patel A, Hashemi M, Laplant J, Fleming J Cureus. 2024; 16(4):e58585.

PMID: 38765324 PMC: 11102658. DOI: 10.7759/cureus.58585.

Teprotumumab in thyroid eye disease.

Goldberg H, Malik A Saudi J Ophthalmol. 2024; 38(1):29-33.

PMID: 38628412 PMC: 11017013. DOI: 10.4103/sjopt.sjopt_179_23.

Long-Term Follow-Up of a Case of Severe Hyperglycemia Requiring Hospitalization after Third Dose of Teprotumumab: A Case Report.

Mehta P, Angell T, LeTran V, Lin M, Nguyen A, Zhang-Nunes S Case Rep Ophthalmol. 2024; 15(1):115-121.

PMID: 38318283 PMC: 10843176. DOI: 10.1159/000536153.

References

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Douglas R, Kahaly G, Patel A, Sile S, Thompson E, Perdok R . Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med. 2020; 382(4):341-352. DOI: 10.1056/NEJMoa1910434. View