FDA Approves First Treatment for Thyroid Eye Disease (Teprotumumab)

The U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). This approval represents the first drug approved for the treatment of thyroid eye disease.

The 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, M.D., deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research. 

Tepezza was approved based on the results of two studies (Study 1 and 2) consisting of a total of 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo.

More from Teprotumumab News:

Teprotumumab Significantly Improves Proptosis in Thyroid eye Disease

Clinical Trial Analyses Substantiate that Teprotumumab Improves Debilitating Effects of TED

FDA Grants Priority Review of Teprotumumab Biologics License Application for the Treatment of TED

More from Teprotumumab Research:

Teprotumumab for the Treatment of Active Thyroid Eye Disease

(Authors: Raymond S. Douglas, George J. Kahaly et. al.)

Teprotumumab in the Treatment of Active TED: A Focus on Proptosis

(Author: Raymond S. Douglas)