Amgen’s Executive Vice President of Research and Development, Dr. Jay Bradner, emphasized the significance of TEPEZZA’s approval in Asia as a milestone for the global treatment of Thyroid Eye Disease (TED). He highlighted the innovation TEPEZZA provides by offering a nonsurgical and nonsteroidal option for patients with TED, addressing the root cause of this debilitating disease.
This approval in Japan was facilitated by TEPEZZA receiving orphan drug designation, leading to a shorter regulatory review period. The approval was based on positive results from the OPTIC-J Phase 3 study, demonstrating TEPEZZA’s efficacy, tolerability, and safety in treating active TED in Japan.
Dr. Yuji Hiromatsu, a prominent figure in the medical community, expressed the importance of TEPEZZA’s approval in Japan, offering a new treatment option that targets the underlying mechanism of TED and alleviates the burden of the disease on patients.
Currently approved in the United States, Brazil, and the Kingdom of Saudi Arabia, TEPEZZA is also under regulatory review in Europe, Canada, and Australia.
Thyroid Eye Disease (TED) is a rare autoimmune disease that poses a serious threat to vision and quality of life for those affected. It stems from autoantibodies activating a receptor within the orbital space, leading to various symptoms such as proptosis, dry eyes, and double vision.
TEPEZZA’s approval in Japan introduces a new standard of care for patients with active TED, expanding treatment options beyond complex surgeries and high-dose steroids. Through its targeted approach, TEPEZZA aims to address the underlying cause of the disease and improve patient outcomes.
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