The U.S. Food and Drug Administration (FDA) recently approved Horizon Therapeutics Ireland DAC’s teprotumumab-trbw (Tepezza) as the first FDA-approved treatment for adults with thyroid eye disease (TED).
TED is a rare disorder which causes the fatty tissues and muscles behind a person’s eyes to become so inflamed, that it causes the eyes to push forward to the point of bulging out. This can lead to several more impactful symptoms, including eye pain and vision impairment.
The deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research describes the impact of this approval: “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.”
The approval also speaks to the FDA’s mission to help advance the quality of care for patients and their families who suffer from rare disorders.
Please read more about teprotumumab-trbw’s approval here.