The recent approval of TEPEZZA in Asia signifies a major step forward in the global treatment of Thyroid Eye Disease (TED), as stated by Dr. Jay Bradner, Executive Vice President and Chief Scientific Officer at Amgen. Traditionally, TED has been managed with complex surgeries and high-dose steroids, which can lead to further complications. TEPEZZA provides a non-surgical, non-steroidal treatment option that addresses the root cause of this debilitating condition.
TEPEZZA has received orphan drug designation in Japan, resulting in a shorter regulatory review period of nine months compared to the standard 12-month review. The approval was based on positive results from the OPTIC-J Phase 3 clinical trial, which demonstrated the efficacy, tolerability, and safety of TEPEZZA in treating active TED in Japan. The trial showed that 89% of patients treated with TEPEZZA experienced a clinically meaningful improvement in proptosis compared to 11% on a placebo.
In addition to Japan, TEPEZZA is currently approved in the United States, Brazil, and the Kingdom of Saudi Arabia, with pending regulatory reviews in Europe, Canada, and Australia. Thyroid Eye Disease (TED) is a rare autoimmune disease that can lead to significant vision-threatening complications. It often occurs in individuals with Graves’ disease and is characterized by autoantibodies activating the insulin-like growth factor-1 receptor (IGF-1R)-mediated signaling complex in the retro-orbital space, resulting in serious long-term damage, including blindness.
The approval of TEPEZZA in Japan offers a new treatment option targeting the underlying mechanism of the disease, providing hope for patients suffering from active TED. Amgen is a leading biotechnology company focused on developing innovative medicines to combat challenging diseases. The company’s dedication to research and development has earned it recognition as one of the “World’s Most Innovative Companies” and “America’s Best Large Employers.” For more information, visit Amgen’s official website and follow them on various social media platforms.
