Tepezza Approved in Japan for Active Thyroid Eye Disease
• Amgen's Tepezza (teprotumumab) has been approved in Japan for treating active thyroid eye disease (TED) or TED with a high clinical activity score (CAS).
• The approval is based on the OPTIC-J study, a Phase 3 trial demonstrating significant improvement in proptosis (eye bulging) in patients treated with Tepezza.
• Tepezza is the first and only medicine approved in Japan for active TED, offering a non-surgical, non-steroidal treatment option.
• A separate Phase 3 trial is ongoing in Japan to study the efficacy of Tepezza in patients with chronic TED and low CAS.
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