The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Sanofi’s teplizumab (Tzield), marking the UK’s first-ever authorised immunotherapy for type 1 diabetes.

Approved for use in adults and children aged 8 years and older with Stage 2 type 1 diabetes (T1D), teplizumab can delay the progression to Stage 3 T1D by an average of three years.

Stage 3 T1D is when people usually begin to experience blood sugar problems and are diagnosed with the condition, which often requires lifelong insulin treatment.   

The approval was granted on 14 August 2025 to Aventis Pharma Ltd, now operating as Sanofi India Ltd, under the International Recognition Procedure (IRP), which allows the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients. 

Teplizumab is administered as a once-daily intravenous infusion over a 14-day course. It is used in people with Stage 2 T1D, which is an earlier stage of the disease where individuals are at high risk of progressing to Stage 3.