February 17, 2022
1 min read
A post-marketing safety analysis showed that the real-world rate of hearing-related events linked with Tepezza treatment was comparable to that found in clinical trials, according to a press release.
The 19-month analysis included data from thousands of patients with thyroid eye disease treated with Tepezza (teprotumumab-trbw, Horizon Therapeutics) since the drug’s FDA approval in 2020.
According to the release, about 10% of all cases reported to the safety database have included a hearing-related event. The most frequent hearing event was hypoacusis, followed by tinnitus. There were no new safety concerns.
In the pooled OPTIC phase 3 and OPTIC-X open-label extension trials, 9.5% of patients who received Tepezza had a hearing-related event compared with 0% of patients who received placebo. These events were mild or moderate and caused few discontinuations or therapy interruptions, according to the release.
“Managing the disabling symptoms of thyroid eye disease can be difficult for patients, both physically and emotionally, and before Tepezza, there was a significant unmet medical need for an effective treatment,” Jeffrey W. Sherman, MD, FACP, executive vice president and chief medical officer at Horizon, said in the release. “Ongoing research reinforces the significant impact Tepezza can have on people living with this devastating disease.”
