FDA Approves New Treatment for Thyroid Eye Disease

Pharmacy Times, June 2020, Volume 88, Issue 6

Teprotumumabtrbw is the first drug to be approved for the treatment of TED.

FDA officials have approved teprotumumab-trbw (Tepezza; Horizon Therapeutics) for the treatment of adults with thyroid eye disease (TED).1

TED is a rare condition in which the fatty tissues and muscles behind the eye become inflamed, causing the eyes to be pushed forward and bulge outward (also known as proptosis). Teprotumumabtrbw is the first drug to be approved for the treatment of TED.1

Women are 5 to 6 times more likely to develop the disease and often have more severe and prolonged activity, threatening their vision, according to investigators at the Kellogg Eye Center at Michigan Medicine in Ann Arbor.2

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

The most common adverse events observed in patients treated with teprotumumab- trbw are alopecia, diarrhea, dry skin, dysgeusia, fatigue, headache, hearing loss, hyperglycemia, muscle spasm, and nausea.1REFERENCES

  • FDA approves first treatment for thyroid eye disease. News release. US Food & Drug Administration. January 21, 2020. Accessed 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
  • Thyroid eye disease (TED or Graves eye disease). Kellogg Eye Center, Michigan Medicine. Accessed May 11, 2020. umkelloggeye.org/conditions-treatments/thyroid-eye-disease