FDA Approves New Drug for Thyroid Eye Disease

The US Food and Drug Administration (FDA) has approved Tepezza (teprotumumab-trbw) for the treatment of thyroid eye disease. It is the first-ever drug to be approved for this indication.

“Today’s approval marks an important milestone for the treatment of thyroid eye disease. Currently, there are very limited treatment options for this potentially debilitating disease. This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non-surgical treatment option,” said Wiley Chambers, MD, deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, in a press release.

Thyroid eye disease is a rare condition that causes the muscles and fatty tissues behind the eye to become inflamed, causing proptosis. This condition is associated with eye pain, double vision, light sensitivity, and/or difficulty closing the eye.

The most commonly reported adverse events associated with use of Tepezza include muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing loss, dry skin, dysgeusia, and headache. Pregnant women should not be treated with Tepezza, and women of childbearing age should receive counseling on pregnancy prevention while using Tepezza and for 6 months after their last dose of Tepezza.

—Christina Vogt

FDA approves first treatment for thyroid eye disease [press release]. US Food and Drug Administration. January 21, 2020. Accessed January 21, 2020.