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01.04.2020 | AdisInsight Report

Teprotumumab: First Approval

verfasst von: Anthony Markham

Erschienen in: Drugs | Ausgabe 5/2020

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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.

US Food & Drug Administration. FDA approves first treatment for thyroid eye disease [media release]. 21 Jan 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease.

Horizon Therapeutics. TEPEZZA (teprotumumab-trbw) for injection, for intravenous use. 2020. https://www.hzndocs.com/TEPEZZA-Prescribing-Information.pdf. Accessed 2020.

Genmab. Genmab announces Rg1507 update [media release]. 4 Dec 2009. http://www.genmab.com.

Genmab. Teprotumumab restarts clinical development in new indication [media release]. 11 Jun 2013. http://www.genmab.com.

Horizon Pharma. Horizon Pharma plc announces agreement to acquire River Vision Development Corp. and teprotumumab (RV001), a biologic in late-stage development for rare eye disease [media release]. 8 May 2017. http://www.horizonpharma.com.

Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active thyroid eye disease. N Engl J Med. 2020;382(4):341–52.CrossRef

Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748–61.CrossRef

Kahaly GJ, Douglas R, Holt RJ, et al. 48-week follow-up of a multicenter, randomized, double-masked, placebo-controlled treatment trial of teprotumumab in thyroid-associated ophthalmopathy [abstract no. Highlighted Oral 2]. Thyroid. 2018;28(Suppl 1):A1.

Titel: Teprotumumab: First Approval
verfasst von: Anthony Markham
Publikationsdatum: 01.04.2020
Verlag: Springer International Publishing
Erschienen in: Drugs / Ausgabe 5/2020
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-020-01287-y

Die Highlights vom Kongress des American College of Cardiology 2024

Springer Medizin

Teprotumumab: First Approval

Abstract

Die Highlights vom Kongress des American College of Cardiology 2024

Springer Medizin

Abstract

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