Amgen’s TEPEZZA® (teprotumumab) Receives Marketing Authorization for Moderate-to-Severe Thyroid Eye Disease in the UK CAMBRIDGE, England—Amgen announced today that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for TEPEZZA® (teprotumumab), making it the first therapy specifically licensed for treating adult patients with moderate-to-severe Thyroid Eye Disease (TED). TED is a progressive and potentially vision-threatening condition that affects approximately 50,000 people in the UK. Symptoms include eye bulging, double vision, eye pain, and significant discomfort, often leading to severe functional and aesthetic issues. TEPEZZA® targets the insulin-like growth factor 1 receptor (IGF-1R), a key player in the pathogenesis of TED. The drug aims to reduce inflammation and muscle swelling, which are major contributors to the condition's symptoms. Prior to this approval, there were limited therapeutic options available for TED, with many patients relying on supportive care measures or surgical interventions that could be invasive and risky. Clinical trials have shown that TEPEZZA® can significantly improve the quality of life for patients with TED. In one pivotal study, over 80% of participants experienced a reduction in proptosis, or eye bulging, and nearly 70% reported improvements in double vision. These results highlight the potential of teprotumumab to address both functional and aesthetic aspects of the disease, providing a non-surgical alternative for patients who might otherwise face more invasive treatments. The MHRA's decision to authorize TEPEZZA® in the UK is based on robust clinical data demonstrating its efficacy and safety. Dr. David M. Reese, Executive Vice President of Research and Development at Amgen, stated, “This authorization marks a significant milestone in the treatment of TED, offering patients a targeted and effective option to manage their condition. We are committed to bringing innovative therapies to those who need them most.” The impact of this approval extends beyond just medical advancements. It represents a step forward in recognizing the seriousness of TED and the need for specialized treatments. For many patients, TEPEZZA® could mean the difference between managing symptoms with limited success and achieving meaningful relief from the disease’s debilitating effects. This is particularly important given that TED often co-occurs with Graves' disease, an autoimmune disorder affecting the thyroid gland. In addition to the UK, teprotumumab has already received approval in several other countries, including the United States and Germany. The global recognition of TEPEZZA® underscores its importance in the realm of ophthalmic and endocrine medicine. Amgen plans to continue expanding access to the drug, ensuring that it reaches as many patients as possible worldwide. For healthcare providers, the availability of TEPEZZA® means they now have a powerful tool to help patients suffering from TED. Clinical guidelines and educational resources will be provided to assist doctors in integrating this new treatment into their practice effectively. This will not only help in patient management but also in raising awareness about the condition and its impact on daily life. In conclusion, the MHRA's authorization of TEPEZZA® is a landmark achievement in the field of TED treatment. It provides a much-needed targeted therapy for patients, reduces the reliance on invasive surgeries, and enhances the overall quality of life for those affected by this condition. Amgen's ongoing commitment to innovation in healthcare promises to bring further benefits to patients around the world.