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Home > About Breakthrough T1D UK & our impact > Our research > Cure research > Immune therapies > FAQs about teplizumab
Teplizumab is an immunotherapy drug, which has just been approved by the Medicines and Healthcare products Regulatory Agency to delay the onset of type 1 diabetes (T1D). It was approved by the USA’s Food and Drug Administration (FDA) in November 2022. It helps to protect the insulin-producing beta cells from the immune attack that causes T1D by attaching to markers on a type of immune cell called T-cells. Teplizumab has been shown to delay the development of T1D in at-risk individuals by an average of three years.
Teplizumab has been authorised for children above eight and adults identified as being stage 2 T1D with two or more autoantibodies.
Teplizumab is the first disease-modifying therapy available to delay clinical T1D in individuals at high risk anywhere in the world. The approval of teplizumab proves to funders of research in government and industry that it is possible to develop drugs for T1D. This should lead to an increase in funding for T1D research and hopefully bring about more treatments.
A delay in T1D of at least two years is clinically meaningful. Any time period that a person does not have to be dependent on insulin means they are avoiding important risks such as hypoglycaemia and the significant constant burdens of life with T1D. This can also play a key role in preventing complications such as eye, kidney, and heart diseases.
The next stage is for the treatment to be analysed by the National Institute for Health and Care Excellence (NICE). NICE is an approval agency which addresses the safety and cost effectiveness of drugs in England and Wales. Before teplizumab is adopted in the NHS, NICE must deem it clinically cost effective. Once it is approved, an education programme for doctors needs to be developed to teach them how to manage people who have stage 2 T1D. Dr Rachel Besser is working on this – read her blog post.
There are trial screening programmes in the UK that test children’s blood for markers of the very early stages of T1D. One of these is called the ELSA study and screens children aged 3-13 years across the UK. Every child between that age bracket is eligible to be screened.
There is also an adult-screening programme called T1DRA, which is open to people aged 18-70.
Researchers have also tested teplizumab in people recently diagnosed with T1D via the PROTECT study. The study was possible thanks to the Breakthrough T1D UK co-funded UK T1D Research Consortium, which recruits people with type 1 into UK clinical trials of new immunotherapy treatments. Recruitment for this study has now closed, but you can use our clinical trials finder to see which other studies you are eligible for.
In the clinical trial under review, some people who took teplizumab developed a rash and had a temporary lower level of white blood cells than they should have. White blood cells are cells within the immune system that help fight off infectious diseases. Crucially, the participants’ white blood cell count soon returned to normal.
Other drugs that target the immune system – known as immunotherapy drugs – are being developed and tested on people with T1D. An example of this is ustekinumab, a drug licensed to treat other autoimmune conditions including psoriasis, which is being trialled in children recently diagnosed with T1D. The approval of teplizumab sets a precedent that immunotherapies are a viable treatment for T1D. This encourages pharmaceutical companies to invest in them and paves the way for more drugs to become available.
As part of our mission to accelerate life-changing breakthroughs, Breakthrough T1D UK played a key role in funding early-stage research and facilitating regulatory pathways to help bring teplizumab to market. As well as co-funding the UK T1D Research Consortium, Breakthrough T1D UK has funded international clinical networks that supported early clinical trials to determine who would benefit from teplizumab, and whether the drug works for people both with and at high risk of T1D.
We have continuously funded a researcher called Professor Kevan Herold, who initially showed that an immunotherapy drug could prevent T1D in mice. This drug later became a version that could be used in humans: teplizumab. Professor Herold was the lead on the first ever study to effectively delay the onset of T1D, which formed the basis of the FDA approval application. He is still receiving Breakthrough T1D UK funding to explore the biological mechanisms through which teplizumab delays T1D development.
Drugs that target our immune system are called immune therapies or immunotherapies. Learn about the immunotherapy research we're funding.
Learn about how we're partnering with other autoimmune research funders to investigate how immune disorders are linked. Together, we aim to prevent and cure a range of autoimmune conditions including type 1 diabetes.
Treating type 1 means helping people achieve better glucose control, with less effort. It also means looking for ways to prevent or cure the complications that can develop from living with type 1. Discover our latest projects.
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