The FDA has updated Horizon Therapeutics’ Tepezza (teprotumumab-trbw)—indicated for the treatment of patients with chronic/low clinical activity score (CAS) thyroid eye disease (TED) with an update to the prescribing information label to include a new warning /precaution for patients: “hearing impairment including hearing loss.”
Refresh me on Tepezza.
Approved by the FDA in 2020 as the first and only treatment indicated for TED, Tepezza is administered via an intravenous injection of 10 mg/kg into the arm followed by 20 mg/kg injection every 3 weeks for 7 additional infusions.
And its warnings and precautions?
The prescribing information initially included two warnings:
- Infusion reactions
- Exacerbation of preexisting inflammatory bowel disease (IBD)
In December 2022, the FDA added hyperglycemia to the list.
Now this latest update.
As of July 20, 2023, the FDA added hearing impairment including hearing loss as the fourth potential warning and precaution.
The label reads: “[Tepezza] may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.”
Wait … wasn’t there also another recent update?
Good memory … the FDA approved an update to Tepezza’s indication in April 2023 that specified its use for the treatment of all TED patients, regardless of the disease activity or duration.
Gotcha. So what brought this addition on?
Research published in May 2023 in Endocrine Practice from two extension studies that assessed the Grave’s Ophthalmopathy Quality of Life (GO-QOL) in Tepezza-treated patients found that the overall baseline GO-QOL score was similar between those with and without hearing-related AEs.
The 20 patients (out of 120 patients using Tepezza) reported 12 hearing-related events (77% which were considered mild) that included:
- Tinnitus
- Hearing loss/impairment
- Hyper/hypoacusis
- Autophony
- Eustachian tube dysfunction
What else?
More recently, Horizon released a series of analyses in June 2023 that assessed hearing-related issues in patients with Graves’ disease and TED (regardless of treatment with Tepezza); the results supported a need to evaluate hearing-related medical history of such patients.
Go on …
To note, Tepezza was originally developed to treat cancer; however, its ineffectiveness led to an eventual indication for TED instead.
In an evaluation of hearing-related AEs in eight oncology clinical trials involving Tepezza found consistent types of AEs with similar incidence already reported in the TED trials and Tepezza’s prescription labeling, according to Horizon.
Any input from the company?
When releasing the analysis data in June 2023, Horizon’s Jeffrey W. Sherman, MD, FACP, executive vice president and chief medical officer (CMO), emphasized the company’s commitment to such research that “supports a positive treatment experience while establishing a positive benefit/risk profile [for Tepezza).”