Amgen’s Tepezza granted marketing authorisation in the UK

Teprotumumab approved as first targeted treatment for thyroid eye disease

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Amgen’s Tepezza (teprotumumab) as the first licensed treatment for adults with moderate-to-severe thyroid eye disease (TED).

TED affects around 50,000 people in the UK, causing eye bulging, double vision, pain and swelling, and significantly impacting patients’ quality of life.

TED can lead to anxiety and depression, with patients often struggling with self-confidence and their ability to carry out daily tasks. Teprotumumab, an immunotherapy targeting the insulin-like growth factor-1 receptor (IGF-1R), is the first treatment designed to address the underlying drivers of the disease rather than generalised inflammation.

Dr Tony Patrikios, executive medical director at Amgen UK & Ireland said: “The marketing authorisation for teprotumumab as the first therapy specifically licensed for thyroid eye disease (TED) in the UK marks a step forward for the patient community.

He added: “TED can negatively affect patients’ lives impacting vision, causing eye pain, making everyday tasks difficult and causing a loss of self-confidence. This authorisation introduces a new alternative treatment option and reinforces Amgen’s commitment to supporting eligible patients with serious, underserved conditions.”

The authorisation is backed by multiple clinical studies, including the phase 3 OPTIC trial, which showed that 83% of patients with active TED experienced a reduction in proptosis (eye bulging) of at least 2mm compared to just 10% in the placebo group.

Amgen is working with the National Institute for Health and Care Excellence (NICE) to secure reimbursement for teprotumumab to ensure access for all eligible patients in the UK.