The UK health watchdog NICE has recommended NHS reimbursement of teplizumab, marking the first disease-modifying treatment in the UK designed to delay the onset of symptomatic type 1 diabetes.

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending teplizumab for NHS use in people aged 8 years and over with stage 2 type 1 diabetes, positioning it as the first immunotherapy in the UK aimed at delaying progression to symptomatic disease.

If finalised, the decision would make teplizumab available across the NHS in England and Wales within 60 to 90 days.

Sanofi said the recommendation represents a major shift in the treatment landscape, with country lead for the UK and Ireland, Ahmed Moussa, stating that NICE has “recognised the value of a therapy that can delay the onset of symptomatic, stage 3 type 1 diabetes,” marking a move towards earlier intervention in disease progression.

He added that the ambition is to reduce the number of patients who first present with the disease during acute diabetic ketoacidosis events, describing a future where “traumatic diagnoses, often following life-threatening diabetic ketoacidosis events, become a rarity.”

Type 1 diabetes is a progressive autoimmune condition that develops over several years, beginning with a silent pre-symptomatic phase in which immune attack on insulin-producing beta cells is already underway.

Breakthrough T1D UK director of policy Hilary Nathan said the recommendation changes the historical treatment paradigm, noting that “for more than 100 years, insulin has been the only treatment for type 1 diabetes” and that NICE’s decision “marks the first therapy able to alter the course of the condition itself.”

She added that the approval marks “a fundamental shift in what diagnosis means,” with potential implications for earlier identification and intervention in at-risk individuals.

The decision is supported by clinical data from the pivotal TN-10 study, where a single 14-day course of teplizumab delayed progression to stage 3 type 1 diabetes by a median of approximately two years compared with placebo.

Clinicians involved in diabetes care said the decision represents a change in clinical thinking. Dr Nick Thomas, clinical lecturer in diabetes and endocrinology, said the guidance is “a step change in how we think about managing type 1 diabetes,” adding that for the first time clinicians can “act to modify the disease” rather than only manage symptoms.

Teplizumab, a humanised anti-CD3 monoclonal antibody, is designed to modulate immune activity and preserve pancreatic beta cell function in individuals with early-stage disease.

Until now, treatment options for type 1 diabetes have been limited to insulin replacement therapy once patients reach symptomatic stage 3 disease.

The TN-10 trial formed a key part of the evidence base considered by NICE, demonstrating that a single treatment course could extend the time to clinical diagnosis by around 25 months compared with placebo, alongside evidence of preserved beta cell function.

Type 1 diabetes affects an estimated 35,000 people under the age of 19 in the UK. The condition can lead to both acute complications such as diabetic ketoacidosis and long-term outcomes including cardiovascular, renal and neurological disease.

Patient identification in earlier disease stages remains limited in routine UK clinical practice, despite the availability of autoantibody testing that can detect disease before symptom onset.

NICE’s recommendation follows the UK government’s recent adjustment of cost-effectiveness thresholds, which has enabled a broader range of innovative therapies to be considered for NHS adoption.

If final guidance is confirmed, teplizumab would become the first therapy in the UK approved specifically to delay progression of type 1 diabetes rather than treat established disease.