Tepezza (teprotumumab-trbw) receives approval in Japan for the treatment of active thyroid eye disease – Amgen

Amgen announced  Tepezza  has been approved for the treatment of active or high clinical activity score (CAS) Thyroid Eye Disease (TED) by Japan’s Ministry of Health, Labour and Welfare (MHLW).

TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling. There are approximately 25,000 – 35,000 people living with TED in Japan, inclusive of both active and chronic (low CAS) TED. Tepezza is now the first and only medicine approved in Japan to treat active TED. A separate trial to study the efficacy of Tepezza in chronic TED patients in Japan is currently ongoing.

“This is the first approval for Tepezza  in Asia and marks a significant milestone for the global treatment of TED,” said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. “Historically, patients with TED have been managed with complex surgeries and high-dose steroids, which can cause further complications. With Tepezza doctors have a nonsurgical and nonsteroidal option that treats a root cause of this debilitating disease.”.