MHRA approves the first Type 1 diabetes immunotherapy in UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved teplizumab (called Tzield) as the UK’s first immunotherapy for Type 1 diabetes. The drug is licensed for adults and children aged 8 years or older with stage 2 Type 1 diabetes to delay progression to stage 3.

The MHRA approval came through its international recognition procedure, which allows the organisation to use the expertise and decision-making of trusted regulatory partners. Teplizumab was approved in the US in 2022 by the Food and Drug Administration after a clinical trial showed it could delay the onset of symptomatic Type 1 diabetes by an average of 3 years in people at high risk who were in the early, symptomless stages.

When stage 3 Type 1 develops, people usually begin to have blood glucose problems and need lifelong insulin treatment. Delaying the progression of diabetes allows people to remain free from insulin treatment, carbohydrate counting and hypoglycaemia for longer. In addition, it helps to maintain healthy blood glucose levels so reducing the risks of long-term complication risks.

Around 400,000 people in the UK have Type 1 diabetes which is the most common type of diabetes in children and young people.

The future…
NICE has not yet recommended teplizumab for routine use in England. While Type 1 diabetes, clinical trials suggest that it may benefit those who are newly diagnosed by protecting around 20% of the remaining beta cells. To ensure that teplizumab reaches everyone who could benefit, it needs to be available on the NHS along with a screening programme to identify those with early-stage Type 1 diabetes.