As a proud sponsor of the Philadelphia Endocrine Society, Medly is diving into the impacts of Thyroid Eye Disease and the significance of Tepezza, the first approved medication for the treatment of adults with thyroid eye disease.
In January of 2020, the U.S. Food and Drug Administration (FDA) approved Tepezza 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.
Tepezza’s approval is significant. Before the drug’s approval, there were very limited treatment options for those living with this potentially debilitating disease. Tepezza, however, has the potential to alter the course of this disease by providing patients with an alternative to surgical treatment, which often involves multiple and invasive operations. Additionally, the approval of Tepezza represents important progress in the approval of effective treatments for rare diseases, such as thyroid eye disease, that impact a small percentage of the population.
Tepezza was approved based on the results of two studies. A total of 170 patients with active thyroid eye disease were randomized to receive Tepezza or a placebo. Of the patients who were administered Tepezza, 71% in the first study and 83% in the second study demonstrated a greater than 2 millimeter reduction in eye protrusion as compared to 20% and 10% of subjects who received the placebo treatment, respectively.
In terms of administration, Tepezza is given once every 3 weeks for a total of 8 IV infusions. Dosing will depend on each individual patient’s weight. The initial dose is 10 mg/kg. The remaining infusions are dosed at 20 mg/kg. Female patients will need to be counseled about using effective contraception prior to initiation, during treatment with Tepezza, and for 6 months after the last dose. In addition, patient’s glucose levels should be monitored for hyperglycemic reactions and patients with preexisting diabetes or impaired glucose tolerance should be under appropriate glycemic control before receiving Tepezza.