The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 7 May 2025, approved teprotumumab (Tepezza). This is the first medicine to be licensed in the UK for adult patients with moderate to severe Thyroid Eye Disease (TED).
TED is an autoimmune condition where the immune system attacks the muscles and fat around the eyes. In TED, the immune system activates a protein called IGF-1R, causing inflammation and swelling in these tissues. Tepezza is designed to bind to IGF-1R to block its activation and signalling.
This medicine is administered via an intravenous drip directly into a vein by a healthcare professional.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said
“Patient safety is our top priority. I am pleased to confirm the approval of teprotumumab, for the treatment of severe Thyroid Eye Disease.
“We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this new treatment have been met.
“As with all products, we will keep its safety under close review.”
Teprotumumab has been studied in 287 patients with thyroid eye disease in four clinical trials. All patients in these trials were 18 years or older. In all studies, patients received teprotumumab infusions every 3 weeks for a total of 8 infusions.
In the four studies patients were randomised to receive either teprotumumab or placebo. The patients who received teprotumumab demonstrated a greater reduction in eye protrusion and double vision compared to people .
Like all medicines, this medicine can cause side effects in some people. Serious side effects can include high blood sugar (hyperglycaemia), infusion related reactions, deafness, or worsening of inflammatory bowel disease.
Other side effects that may affect up to 1 in 10 people include headache, diarrhoea, nausea, hair loss, muscle spasms and fatigue.
Tepezza must not be used in patients if they are pregnant as it may cause damage to the unborn baby.
Anyone who suspects they are having a side effect from this medicine should talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https//yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
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The new marketing authorisation was granted on 7 May 2025 to AMGEN LIMITED
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This product was submitted and approved via a national procedure.
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
