An immunotherapy has been approved by the UK medicines regulator to delay the development of type 1 diabetes for people in the early stages of the condition.
Teplizumab has become the UK’s ‘first-ever’ approved immunotherapy for type 1 diabetes in a move that has been described as ‘a turning point’ in the treatment of the condition.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it had approved the use of teplizumab (Tzield) to delay the onset of stage 3 type 1 diabetes in adults and children aged eight years and older with stage 2 type 1 diabetes.
It has been found that it can delay development of stage 3 by an average of three years and the MHRA said it would be the UK’s ‘first-ever’ approved immunotherapy for type 1 diabetes.
However, it is not currently available on the NHS.
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Teplizumab is licensed for people aged eight years and over, and is administered once a day via intravenous infusion for 14 days.
The medicine is for people with stage 2 type 1 diabetes, where individuals are at high risk of progressing to stage 3.
Stage 3 type 1 diabetes is when people usually begin to experience blood sugar problems which often require lifelong insulin treatment.
The medicine works by slowing the immune system’s attack on insulin-producing beta cells, delaying the development of stage 3 type 1 diabetes.
It was approved through the International Recognition Procedure (IRP) which allows the MRHA to consider the expertise and decision-making of trusted regulatory partners for the benefit of UK patients.
Leading charity Diabetes UK welcomed the move but stressed the need for teplizumab to be made available on the NHS.
Dr Elizabeth Robertson, director of research and clinical at Diabetes UK, said: ‘[The] landmark licensing of teplizumab in the UK marks a turning point in the treatment of type 1 diabetes.
‘For the first time, we have a medicine that targets the root cause of the condition, offering up to three precious extra years from the relentless demands of managing type 1 diabetes.’
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She added: ‘This is a breakthrough moment, but the next steps are critical.
‘To ensure teplizumab reaches everyone who could benefit, we need it to be made available on the NHS, and the rollout of a screening programme to identify those with early-stage type 1 diabetes.’
Alongside the MHRA’s review, the National Institute for Health and Care Excellence (NICE) has been assessing the clinical and cost effectiveness of teplizumab, and whether it should be available through the NHS.
On 7 August 2025, the committee said they could not recommend teplizumab because ‘more evidence is needed’. The draft guidance that was published following this announcement described uncertainties about: the population eligible for teplizumab, the costs of managing stage 3 type 1 diabetes, and the effects of stage 3 type 1 diabetes on quality of life.
Diabetes UK said it was disappointed by this initial decision and would be ‘putting forward evidence and amplifying the voices of the type 1 diabetes community to make the case for the difference teplizumab could make’. Particularly with the prevalence of diabetes rising at an ‘alarming rate’.
NICE is expected to publish updated guidance on 26 November 2025.
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A full list of teplizumab’s side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website.
The MHRA will keep the safety and effectiveness of teplizumab under close review.
Anyone who experiences side effects from this medicine can report it directly to the MHRA Yellow Card scheme.
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