First Disease-Modifying Type 1 Diabetes Treatment licensed to delay the onset of symptomatic Stage 3 autoimmune type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with Stage 2 T1D

First Disease-Modifying Type 1 Diabetes Treatment licensed to delay the onset of symptomatic Stage 3 autoimmune type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with Stage 2 T1D 

• Marketing authorisation has been granted via the MHRA’s International Recognition Procedure (IRP) using the FDA as the reference regulator 

• A review by the National Institute for Health and Care Excellence (NICE) is currently underway, which will inform whether eligible patients can access teplizumab in England and Wales 

Reading, THURSDAY, 14 August 2025. Sanofi today announces that teplizumab, a humanized anti-CD3 monoclonal antibody ⁱ, the first of an emerging class of disease modifying treatments, has been authorised by the Medicines and Healthcare Regulatory Agency (MHRA). It has been licenced to delay the onset of symptomatic Stage 3 autoimmune type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with Stage 2 T1D. ⁱ Following authorisation in the US, the UK is the first country in Europe to be granted a licence. Until now, available options have focused solely on managing the symptomatic disease.ⁱⁱ  

Type 1 Diabetes is an autoimmune, complex, and lifelong condition – and it can happen at any age even without family history.ⁱⁱⁱ It is growing in prevalence in the UK, with approximately 400,000 people living with T1D, of which around 32,000 people are aged 19 years or younger.^iv,v It is known that T1D is not caused by diet or lifestyle, but the causes of T1D are currently not fully understood. T1D 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. By stage 3 most of the insulin-producing cells are destroyed and people become symptomatic. ^vi,vii 

From stage 3, people experience symptoms like increased thirst and weight loss; this is usually when they are diagnosed. ^vi,vii 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.^viii Beyond the immediate physical demands, T1D carries a psychological toll, impacting mental health, social activities, and overall quality of life.^ix The long-term complications of the disease include kidney disease, nerve damage, blindness, and cardiovascular issues.^x  

Teplizumab is authorised to delay the onset of symptomatic Stage 3 autoimmune type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with Stage 2 T1D.ⁱ  Teplizumab has been the subject of multiple clinical studies involving more than 1,000 subjects with more than 800 patients receiving teplizumab.^xi  The pivotal TN-10 study demonstrated the capability of teplizumab to preserve beta cell function and reduce the need for exogenous insulin usage in newly diagnosed patients.  A single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease to Stage 3 T1D 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 T1D diagnosis. The observed adverse events were lymphopenia, leukopenia, neutropenia, blood bicarbonate decreased, and rash. More serious, but rarer reactions included cytokine release syndrome, decreased haemoglobin, thrombocytopenia, liver enzyme and bilirubin elevations.ⁱ 

Parth Narendran 

Professor of Diabetes Medicine, University of Birmingham, and The Queen Elizabeth Hospital Birmingham

“Teplizumab essentially trains the immune system to stop attacking the beta cells in the pancreas, allowing the pancreas to produce insulin without interference. This can allow eligible patients to live normal lives, delaying the need for insulin injections and the full weight of the disease's daily management by up to three years. It allows people to prepare for disease progression rather than facing an abrupt emergency presentation.” 

Karen Addington MBE 

Chief Executive, Breakthrough T1D UK 

“After years of research supported by Breakthrough T1D, I am delighted by the MHRA’s authorisation of teplizumab. We now have an immunotherapy that can delay the development of symptomatic type 1 diabetes (T1D) and may help families avoid life-threatening complications, like diabetic ketoacidosis (DKA). What teplizumab offers is time free from the daily challenges of T1D management, a potential reduced risk of serious complications, and the possibility of an improved quality of life." 

Ahmed Moussa  

General Manager, General Medicines UK and Ireland, Sanofi 

“One hundred years ago, the discovery of insulin revolutionised diabetes care. Today’s news marks a big step forward. We are now working with reimbursement bodies with the hope of securing timely access for eligible patients across England and Wales.”  

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the Summary of Product Characteristics for how to report adverse reactions.