Amgen's TEPEZZA Approved In Japan For Treatment Of Active Thyroid Eye Disease

(RTTNews) - Amgen (AMGN) said that Japan's Ministry of Health, Labour and Welfare approved TEPEZZA (Teprotumumab) for the treatment of active or high clinical activity score (CAS) Thyroid Eye Disease or TED.

In addition to Japan, TEPEZZA is currently approved in the United States, Brazil and the Kingdom of Saudi Arabia, and is under regulatory review in Europe, Canada and Australia.

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 (jRCT2031210453), 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.

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