MHRA approves teprotumumab as the first UK treatment for adults with moderate to severe Thyroid Eye Disease (TED)

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.

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 who received placebo.

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.