The National Institute for Health and Care Excellence (NICE) has recommended the first drug to delay the onset of symptomatic type 1 diabetes mellitus (T1DM) for use on the NHS in England and Wales.
In final draft guidance, published on 23 June 2026, NICE recommended teplizumab (Tzield; Sanofi) as a treatment option for adults and children aged eight years and older with stage 2 T1DM.
Teplizumab, which is given intravenously as a one-time course and must be administered once per day for 14 days in a row, can delay the onset of T1DM symptoms for up to three years.
Stages one and two of T1DM are asymptomatic, while symptoms appear in stage three, the guidance adds.
The immunotherapy drug works by binding to a protein on the surface of the T-cells, which in T1DM, attack the pancreas’ insulin-producing cells, NICE said.
To inform its approval of the drug, NICE looked at evidence from the TN-10 clinical trial, published in 2019, which included 76 participants aged eight years and over with stage three T1DM who were first-degree relatives of people with stage three of the disease.
In the extended follow-up period of this trial, the development time to the onset of stage three T1DM was 59.6 months in those taking teplizumab, compared with 27.1 months in the placebo arm, the study results showed.
In a statement published alongside the draft guidance, NICE estimated that around 1,100 people could be eligible for teplizumab across England and Wales in the first year of the NHS providing it, decreasing to a steady state of approximately 820 eligible patients annually from year three onwards.
Helen Knight, director of medicines evaluation at NICE, said: “This is a genuinely exciting recommendation. For the first time, we have a treatment that can give people diagnosed at an early stage of T1DM precious extra time before they need to manage the full demands of the condition.”
Commenting on the guidance, Philip Newland-Jones, consultant pharmacist in diabetes and endocrinology at the University of Southampton, said: “This is a genuinely significant development for T1DM care. For the first time, we have a disease modifying therapy that targets the underlying autoimmune process, rather than simply managing hyperglycaemia once symptoms develop. It represents an important shift towards earlier intervention and prevention-focused care.
“From a pharmacy perspective, this introduces a novel immunotherapy into diabetes care. However, there are practical challenges to be overcome with 14 days of consecutive intravenous treatment, requiring robust governance around patient selection, monitoring and adverse effect management. Pharmacy teams will play a key role in supporting safe implementation, service design and ensuring cost effective use.”
Newland-Jones added: “The ability to delay the onset of symptomatic T1DM by around three years has a different level of significance for different individuals. In some individuals, particularly children and families, it offers additional time free from the daily burden of insulin therapy, glucose monitoring and the psychosocial impact of a life-long condition.
“That time can be crucial for development, education and family adjustment.”
Elizabeth Robertson, director of research and clinical at Diabetes UK, said: “This is an extraordinary moment for celebration in the T1DM community and towards a future where T1DM can be prevented altogether.”
