Sanofi’s teplizumab becomes first licensed disease-modifying treatment in the UK to delay the onset of symptomatic type 1 diabetes

NICE has issued final draft guidance recommending teplizumab for NHS reimbursement, positioning the drug as the UK’s first immunotherapy for delaying the onset of stage 3 type 1 diabetes in people 8 years and over with stage 2 type 1 diabetes.

Subject to NICE final guidance, the treatment is expected to be available to eligible patients within 60 days in Wales, and 90 days in England.

Teplizumab is a humanised anti-CD3 monoclonal antibody and the first of an emerging class of disease modifying treatments. It is indicated to delay the onset of Stage 3 type 1 diabetes in adults and paediatric patients aged 8 years and older with Stage 2 type 1 diabetes.

Until now, available treatment options have focused solely on managing the symptomatic disease. This recommendation paves the way for this treatment for type 1 diabetes to be made available to eligible patients in the UK, subject to final guidance.

This draft recommendation has been made possible by the UK Government’s decision to uplift the NICE QALY cost effectiveness threshold in April 2026, to enable more innovative treatments to reach NHS patients in the UK.

The NICE decision was informed by a range of clinical data including the pivotal TN-10 study, where a single 14-day course of teplizumab delayed the median onset of stage 3 type 1 diabetes by approximately two years compared to placebo. There is estimated to be around 35,000 people under the age of 19 living with the condition in the UK. A Sanofi-funded survey of 200 people with type 1 diabetes revealed that nearly 4 in 10 (38%) people living with type 1 diabetes have required an A&E visit in the past year.

 Ahmed Moussa, Country Lead, UK and Ireland, Sanofi, said: “Today NICE has recognised the value of a therapy that can delay the onset of symptomatic, stage 3 type 1 diabetes, representing a significant step towards a future care model that prioritises early intervention. Our vision is a future where traumatic diagnoses, often following life-threatening Diabetic Ketoacidosis (DKA) events, become a rarity.

“By identifying at-risk individuals earlier, we can help prevent DKA through proactive glucose monitoring and timely intervention. Aligning to the NHS’s 10-year health plan, we are committed to working with the NHS and the entire T1D community to not only ensure rapid access to this and future therapies but also to help build the vital infrastructure that will truly change the paradigm of care for type 1 diabetes in the UK.”

Dr Nick Thomas, Clinical Lecturer in Diabetes and Endocrinology, said: “The final draft guidance from NICE marks a step change in how we think about managing type 1 diabetes. In every clinic, I’m reminded by my patients just how much of a full-time job living with type 1 diabetes is. For the first time, we can now act to modify the disease. Through access to this innovation, eligible patients with early-stage type 1 diabetes will gain invaluable time to prepare for disease progression, helping to make a diagnosis a little more manageable and less traumatic.”

Director of Policy at Breakthrough T1D Hilary Nathan added: “For more than 100 years, insulin has been the only treatment for type 1 diabetes. NICE’s recommendation of teplizumab for NHS use changes that. This is the first therapy able to alter the course of the condition itself, delaying its onset and marking a new era in how type 1 diabetes is treated. This is a triumph of medical research, marking a fundamental shift in what diagnosis means. It also strengthens the case for earlier identification of type 1 diabetes, so people can benefit from treatments like teplizumab before they become unwell and gain more years of health.

“But this approval is just the start. Breakthrough T1D UK hope it will open the door to future immunotherapies that we believe, over time, could be used in combination. We believe that by turning research into reality, we will identify people before they become ill, treat type 1 diabetes earlier and more effectively, and move towards a future where insulin dependence is no longer inevitable. The future starts now with this approval.”

Type 1 diabetes is a lifelong condition that can happen to anyone, no matter their age, family history, or lifestyle choices. If a parent or sibling has type 1 diabetes, the chance of developing the condition can increase by up to 15 times. Type 1 diabetes develops gradually in three stages over months or years. Long before symptoms appear, the immune system mistakenly attacks the insulin-producing cells in the pancreas. Early stages of type 1 diabetes can be reliably identified through testing for autoantibodies and monitoring for when blood glucose is too high or too low, known as dysglycaemia. Although currently this is not conducted routinely in clinical practice in the UK. By stage 3 most of the insulin-producing cells are destroyed and people become symptomatic.

From stage 3, people experience symptoms like increased thirst and weight loss; this is usually when they are diagnosed. Once diagnosed, they face a daily regimen of multiple insulin injections or pump use, continuous glucose monitoring, strict dietary management, and the risk of acute complications, including diabetic ketoacidosis, a potentially life-threatening condition. Beyond the immediate physical demands, type 1 diabetes carries a psychological toll, impacting mental health, social activities, and overall quality of life. The long-term complications of the disease include kidney disease, nerve damage, eye problems, and cardiovascular issues.

Teplizumab is authorised to delay the onset of symptomatic stage 3 autoimmune type 1 diabetes in adult and paediatric patients 8 years of age and older with Stage 2 type 1 diabetes. Teplizumab has been the subject of multiple clinical studies involving more than 1,000 subjects with more than 800 patients receiving teplizumab. The TN-10 study demonstrated the capability of teplizumab to preserve beta cell function. A single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease to Stage 3 type 1 diabetes diagnosis by a median time of 50 months from randomisation in the trial group (n=44) and 25 months in the placebo group (n=32), for a difference of 25 months. The primary endpoint in this study was the time from randomisation to development of Stage 3 type 1 diabetes diagnosis. The most common adverse reactions (occurring in ≥1/10 of patients) were lymphopenia, leukopenia, neutropenia, decreased haemoglobin, thrombocytopenia, decreased blood bicarbonate, decreased blood calcium, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), headache, nausea, rash, pruritus, and pyrexia. Other common adverse reactions (occurring in ≥ 1/100 to <1/10 of patients) included cytokine release syndrome, nasopharyngitis, diarrhoea, urticaria, and chills.