Amgen's TEPEZZA approved in UK for moderate-to-severe Thyroid Eye Disease
Amgen has received marketing authorisation in the United Kingdom for TEPEZZA® (teprotumumab), the first targeted treatment specifically for adults with moderate-to-severe Thyroid Eye Disease (TED). The approval addresses a significant unmet need for the estimated 50,000 people affected by TED in the UK.
Amgen announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for TEPEZZA® (teprotumumab). This approval makes teprotumumab the first therapy specifically licensed for the treatment of adult patients suffering from moderate-to-severe Thyroid Eye Disease (TED) in the United Kingdom.
Thyroid Eye Disease affects an estimated 50,000 individuals in the UK. It is a progressive autoimmune condition that can lead to vision impairment, eye pain, and changes in facial appearance, significantly impacting patients' quality of life, mental wellbeing, and ability to perform daily tasks.
Teprotumumab targets the insulin-like growth factor-1 receptor (IGF-1R), believed to be a key driver in the development of TED. Clinical trials, including the Phase 3 OPTIC study, demonstrated efficacy, with 83% of patients treated with teprotumumab showing a reduction in proptosis (eye bulging) of at least 2mm compared to 10% in the placebo group.
Amgen will now work with the National Institute for Health and Care Excellence (NICE) to seek reimbursement for teprotumumab, aiming to make the treatment accessible to all eligible patients. This authorization expands the availability of the treatment, which has previously been approved in other major markets.