The FDA approved Horizon Therapeutics’ Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition in which the muscles and fatty tissue behind the eye become inflamed, causing the eyes to bulge.
Tepezza is the first drug approved for the condition. The approval was based on the results of two studies of 170 patients with active thyroid eye disease. Of the patients who were administered Tepezza, 71 percent in one study and 83 percent in the other demonstrated a greater than 2-millimeter reduction in eye protrusion.
An FDA advisory committee unanimously voted in favor of the drug.