FDA Approves Teprotumumab-trbw For Treatment of Thyroid Eye Disease

Officials from the FDA have approved teprotumumab-trbw (Tepezza, Horizon Therapeutics) for the treatment of adults with thyroid eye disease.

Thyroid eye disease is a rare condition in which the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (also known as proptosis). Teprotumumab-trbw is the first drug to be approved for the treatment of thyroid eye disease.

The drug was approved based on the results of 2 studies, Study 1 and Study 2, consisting of 170 patients with active thyroid eye disease. Each patient was randomized to either receive teprotumumab-trbw or a placebo. Seventy-one percent of the patients in Study 1 and 83% in Study 2 who received teprotumumab-trbw demonstrated a greater than 2-millimeter reduction in proptosis, compared with 20% and 10% of patients, respectively, who received placebo.

The most common adverse reactions observed in patients treated with teprotumumab-trbw are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing loss, dry skin, dysgeusia, and headache.

REFERENCE

FDA approves first treatment for thyroid eye disease [news release]. Silver Springs, MD; FDA: January 21, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease?utm_campaign=FDA%20approves%20new%20treatment%20for%20thyroid%20eye%20disease%20%E2%80%93%20Drug%20Information%20Update&utm_medium=email&utm_source=Eloqua. Accessed January 21, 2020.