FDA clears Horizon Therapeutics’ Tepezza

The Food and Drug Administration has approved the first treatment for thyroid eye disease. The FDA gave its blessing to Horizon Therapeutics Ireland for Tepezza (teprotumumab-trbw), a treatment for adults with the rare condition in which the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outward.

"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," said Wiley Chambers, deputy director of the division of transplant and ophthalmology products in the FDA's Center for Drug Evaluation and Research. "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."

Thyroid eye disease is associated with the outward bulging of the eye that can cause a variety of symptoms such as eye pain, double vision, light sensitivity or difficulty closing the eye. This disease impacts a relatively small number of Americans, with more women than men affected.

Although this condition impacts relatively few individuals, thyroid eye disease can be incapacitating. For example, the troubling ocular symptoms can lead to the progressive inability of people with thyroid eye disease to perform important daily activities, such as driving or working.