Amgen announces approval of TEPEZZA to treat CAS or TED in Japan

Amgen announced TEPEZZA has been approved for the treatment of active or high clinical activity score, or CAS, Thyroid Eye Disease, or TED, by Japan’s Ministry of Health, Labour and Welfare, or MHLW. TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis, or eye bulging, diplopia, or double vision, eye pain, redness and swelling. There are approximately 25,000 – 35,000 people living with TED in Japan, inclusive of both active and chronic TED. TEPEZZA is now the first and only medicine approved in Japan to treat active TED. A separate trial to study the efficacy of TEPEZZA in chronic TED patients in Japan is currently ongoing. TEPEZZA received orphan drug designation in Japan, which provided a nine-month regulatory review period compared to the standard 12-month review. The approval was based on the positive results of OPTIC-J, a Phase 3 randomized, double-masked, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, tolerability and safety of TEPEZZA in the treatment of patients with active TED in Japan. The primary endpoint in the trial was met, as 89% of patients treated with TEPEZZA had a clinically meaningful improvement in proptosis compared with placebo at week 24.