The first-ever immunotherapy for type 1 diabetes has been licensed for use in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) has decided teplizumab, also known as Tzield, is safe and effective at delaying the development of type 1 diabetes for people in the early stages of the condition.
This is a milestone moment and the beginning of a new era for type 1 diabetes treatment. Teplizumab tackles the root cause of type 1 diabetes – the immune system attack on insulin-making beta cells. By slowing this attack, teplizumab can protect beta cells and hold off a type 1 diabetes diagnosis for around three years on average.
It has been licensed for people aged 8 and over in the UK who are in the early stages of type 1 diabetes, before symptoms appear and type 1 diabetes has fully developed. But it’s not yet available on the NHS.
In the UK, the MHRA is responsible for ensuring that new medicines meet exact standards. After examining all the evidence from clinical trials, it has decided teplizumab is safe and effective and can be licensed for use in the UK.
This moment has been decades in the making. In 1979, Diabetes UK scientists first discovered that disrupting the immune system could alter the course of type 1 diabetes. It sparked a new era in research. Since then, we've invested millions to understand the type 1 immune attack and develop treatments that target it.
We also launched the UK Type 1 Diabetes Research Consortium – a national network of 30 research centres dedicated to speeding up immunotherapy research and bringing them to people sooner.
What happens next?
This announcement is a positive step forward. But there’s still much work to do before people in the UK can benefit from teplizumab.
Teplizumab is not available yet on the NHS. For this to change, the National Institute for Health and Care Excellence (NICE) must complete a review to assess if it offers value for the NHS and make recommendations about who should have access to it.
Their review is currently underway and we'll update you when we hear more.
For teplizumab to reach the people who could benefit from it, there also needs to be screening initiatives in place to identify people in the early stages of type 1 diabetes.
We’ve been leading the way to make type 1 diabetes screening programmes a reality. This includes funding vital research like the BOX study, ELSA study and UK Islet Autoantibody Registry. As well as working with the NHS to bring research advances into clinical practice.
How does screening work?
Screening programmes work by detecting type 1 diabetes autoantibodies – proteins in the blood made by the immune system.
If someone doesn’t have any symptoms of type 1 diabetes yet, but a blood test picks up two or more autoantibodies, it means their immune system has already started destroying their beta cells in the pancreas - although many will still be alive and making insulin. We call this early-stage type 1 diabetes.
Finding people at this stage opens a window to act early by using immunotherapies like teplizumab to protect beta cells before too many are lost – so the pancreas can keep making enough of its own insulin.
In the future, it’s hoped immunotherapies could go even further and hold off the type 1 diabetes immune attack for much longer, possibly for life.
Dr Elizabeth Robertson, Director of Research and Clinical at Diabetes UK, said:
“Today's 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.
“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.
“Diabetes UK is leading the charge, driving type 1 diabetes screening initiatives, funding world-class immunotherapy research, and working with the NHS to make sure no one is left behind. Our vision is a future where multiple immunotherapies are available to stop type 1 diabetes in its tracks, at its earliest stages and beyond."
