Tepezza approved in Japan for active thyroid eye disease

(Image Credit: AdobeStok/soraneko)

Amgen announced that Tepezza(teprotumumab [Genetical Recombination]) was approved by Japan's Ministry of Health, Labour and Welfare to treat active thyroid eye disease (TED) or TED with a high clinical activity score (CAS).

TEPEZZA is the first and only medicine approved in Japan to treat active TED.

An estimated 25,000 to 35,000 people in Japan have TED. This includes active and chronic (low CAS) TED.¹ A separate phase 3 trial (jRCT2031220730) is ongoing in Japan to study the efficacy of Tepezza in patients with chronic TED and low CAS.

"People living with active TED can experience a significant burden of disease with symptoms that can make daily life difficult to navigate," stated Yuji Hiromatsu, MD, a professor emeritus at the Kurume University Medical Center and a physician at the Diabetes, Thyroid and Endocrine Center at the Shin-Koga Hospital. "The approval of TEPEZZA in Japan is an important advancement for patients and offers a new treatment option that targets the underlying mechanism of the disease."

OPTIC-J study

Tepezza received orphan drug designation in Japan, which provided a 9-month regulatory review period compared to the usual 12-month review. The approval was based on the positive results of the OPTIC-J study (jRCT2031210453), a phase 3, randomized, double-masked, placebo-controlled, parallel-group, multicenter study that evaluated the efficacy, tolerability, and safety of Tepezza for treating patients with active TED in Japan, the company explained in a press release

The primary endpoint, the clinically meaningful improvement in proptosis, was met in the study, with 89% of patients treated with Tepezza having an improvement in proptosis of 2 mm or more compared with placebo at 11% at week 24. This result reached significance (p<0.0001).

The safety profile was consistent with the complete body of clinical data supporting Tepezza.²

Tepezza is approved in the United States, Brazil, and the Kingdom of Saudi Arabia and is under regulatory review in Europe, Canada, and Australia.

References

1. Natsuko W, Kozaki A, Inoue K, et al. Prevalence, incidence, and clinical characteristics of thyroid eye disease in Japan. J Endocr Soc. 2023;8:bvad148.

2. Hiromatsu Y, et al. Efficacy and safety of teprotumumab in Japanese patients with active thyroid eye disease. The 66th Annual Meeting of the Japan Thyroid Association, December 9, 2023. Abstract No.O13-5.