The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 14 August 2025, approved teplizumab (Tzield) to delay the onset of Stage 3 type 1 diabetes (T1D) by an average of three years in adults and children aged 8 years and older with Stage 2 T1D. Teplizumab is the UK’s first-ever approved immunotherapy for type 1 diabetes.
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.
Teplizumab 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.
This medicine has been approved through the International Recognition Procedure (IRP). The IRP 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 via intravenous infusion once daily for 14 days.
The MHRA conducts a targeted assessment of IRP applications and retains the authority to reject applications if the evidence provided is not considered sufficiently robust.
A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.
As with any medicine, the MHRA will keep the safety and effectiveness of teplizumab under close review.
Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
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The approval was granted on 14 August 2025 to Aventis Pharma Limited.
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This product was submitted and approved via the International Recognition Procedure.
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.
