Amgen (NASDAQ: AMGN), a prominent biotechnology company based in the U.S., has announced that its drug Tepezza (teprotumumab, genetical recombination) has received market approval in Japan. The country’s Ministry of Health, Labour, and Welfare (MHLW) has authorized the medication for treating active or high clinical activity score (CAS) thyroid eye disease (TED).
TED is a rare autoimmune condition that can be severely debilitating and potentially vision-threatening. It is frequently associated with Graves’ disease and is caused by autoantibodies that activate an insulin-like growth factor-1 receptor (IGF-1R) on cells, leading to a cascade of effects that can result in proptosis, diplopia, eye pain, redness, swelling, and in severe cases, blindness. Japan is home to an estimated 25,000-35,000 individuals suffering from both active and low CAS TED.
The approval was supported by the positive outcomes of the OPTIC-J (jRCT2031210453) study, a Phase III randomized, double-masked, placebo-controlled, parallel-group, multicenter trial. The study demonstrated that 89% of patients treated with Tepezza experienced a clinically meaningful reduction in proptosis compared to 11% in the placebo group at week 24.
As the first and only medicine approved to treat TED in Japan, Tepezza has established a new standard of care for patients. The drug is already approved in the United States, Brazil, and the Kingdom of Saudi Arabia and is currently under regulatory review in Europe, Canada, and Australia.- Flcube.com
