Amgen’s Tepezza Becomes First Licensed Treatment for Thyroid Eye Disease
In a significant breakthrough for patients living with thyroid eye disease (TED), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Amgen’s Tepezza (teprotumumab).
This marks the first time a treatment specifically developed for moderate-to-severe TED has been officially licensed in the United Kingdom.
Thyroid eye disease is a rare but debilitating autoimmune condition that affects approximately 50,000 people in the UK. Characterised by symptoms such as eye bulging (proptosis), double vision, pain, and swelling, TED can severely impact patients’ physical appearance, vision, and overall quality of life.
Beyond the physical effects, many sufferers experience anxiety, depression, and a loss of self-confidence, often finding it difficult to carry out everyday tasks.
Tepezza represents a turning point in the treatment of TED. Unlike previous therapies which primarily addressed inflammation, teprotumumab is the first treatment to directly target one of the disease’s underlying drivers – specifically the insulin-like growth factor-1 receptor (IGF-1R).
This innovative immunotherapy offers a new level of hope to patients who have had few, if any, treatment options up until now.
An Executive Medical Director at Amgen UK & Ireland, hailed the authorisation as a milestone moment, commenting that TED can negatively affect patients’ lives in profound ways – impacting their vision, causing eye pain, limiting day-to-day functioning, and diminishing self-confidence.
The authorisation of teprotumumab provides a new and meaningful option for patients and reinforces Amgen’s commitment to supporting people living with serious, underserved conditions.
The regulatory approval is underpinned by robust clinical data, including the phase 3 OPTIC trial. The trial revealed that 83% of patients with active TED who received teprotumumab experienced a reduction in proptosis of at least 2mm, in stark contrast to just 10% of those in the placebo group.
This tangible improvement not only reflects the drug’s efficacy but also underscores its potential to transform patients’ lives.
Amgen is now actively engaging with the National Institute for Health and Care Excellence (NICE) to ensure that teprotumumab is accessible to all eligible NHS patients across the UK. Securing reimbursement will be a critical step in bringing this promising therapy into clinical practice and alleviating the burden on patients and healthcare providers alike.
Conclusion
The MHRA’s approval of Amgen’s Tepezza marks a pivotal advancement in the treatment landscape for thyroid eye disease in the UK. As the first therapy licensed to specifically address the root causes of TED, teprotumumab holds promise for thousands of patients who have long awaited a tailored treatment solution.
Backed by compelling clinical data and supported by Amgen’s ongoing collaboration with NICE, this authorisation not only delivers a beacon of hope but also signals a broader shift towards targeted innovation in treating complex autoimmune conditions.
News Credits: Amgen’s Tepezza granted marketing authorisation in the UK
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