24 September 2024 - Amgen today announced Tepezza (teprotumumab) has been approved for the treatment of active or high clinical activity score thyroid eye disease by Japan's MHLW.
The approval was based on the positive results of OPTIC-J, a Phase 3 randomised, double-masked, placebo-controlled, parallel-group, multi-centre trial evaluating the efficacy, tolerability and safety of Tepezza in the treatment of patients with active thyroid eye disease in Japan.