History of Tepezza

The FDA approved Tepezza in January 2020, granting the drug application Priority Review, as well as Fast Track and Breakthrough Therapy designation, which expedited the agency’s review process and allowed the medication to enter the market earlier than it would have otherwise. The FDA’s approval of Tepezza was based on the results of two clinical trials (Study 1 and 2), which consisted of a total of 170 patients with active TED. According to the FDA, one of the most common adverse reactions in patients treated with Tepezza was hearing loss. In phase 2 and 3 trials of Tepezza, 85% of patients given the Thyroid Eye Disease medication experienced adverse events, with 10% of patients reporting hearing loss symptoms, compared to 0% of patients given the placebo. In order to better understand the connection between Tepezza and hearing loss symptoms, the researchers followed 28 patients who received at least four Tepezza infusions at a single institution. Of these patients, 13 (46%) reported experiencing hearing symptoms, the most common being hearing loss, muffled hearing, and autophony, or an ear plugging sensation. Additionally, the researchers found that the Tepezza patients who complained of hearing problems did not experience a significant improvement in their symptoms even months after stopping Tepezza treatment.