Tepezza (teprotumumumab-trbw), a first of its kind medication for adults with thyroid eye disease, has recently been granted approval by the US Food and Drug Administration (FDA).
The approval was based on the positive results of 2 studies involving one hundred and seventy adults with the disease. Patients were randomly selected to receive a placebo or Tepezza, and early results showed that those administered with Tepezza demonstrated a two-millimetre or more reduction in proptosis compared to those who were given the placebo.
“Tepezza (teprotumumumab-trbw) has been approved by the US FDA.“
Deputy Director of the Division of Ophthalmology and Transplant products in the FDA’s Center for Drug Evaluation and research, Wiley Chambers, M.D., stated: “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. Additionally, thyroid eye disease is a rare disease that impacts a small percentage of the population and for a variety of reasons treatments for rare diseases are often unavailable. This approval represents important progress in the approval of effective treatments for rare diseases such as thyroid eye disease.”