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The Medicines and Healthcare products Regulatory Agency (MHRA) has approved teplizumab (Tzield; Sanofi) for delaying the progression of type 1 diabetes mellitus (T1DM).
The treatment is the UK’s first approved immunotherapy for the disease and has been licensed for patients aged 8 years and over. It is administered through an intravenous infusion once daily for 14 days.
On 14 August 2025, the MHRA said that teplizumab delays the onset of stage 3 of T1DM by an average of three years in adults, and children with stage 2 of the disease.
In earlier stages of the disease, patients are asymptomatic but will test positive for diabetes-related autoantibodies, meaning their immune system has started to destroy beta cells in the pancreas.
Using an immunotherapy in these earlier stages can protect beta cells before too many are lost, allowing the pancreas to continue making insulin.
It is estimated that around 460,000 people in the UK have T1DM, which can develop over months or years.
Commenting on the approval, Parth Narendran, professor of diabetes medicine at University of Birmingham and consultant at the Queen Elizabeth Hospital Birmingham, said the treatment “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, chief executive of the charity Breakthrough T1D UK, said: “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 and may help families avoid life-threatening complications, like diabetic ketoacidosis.
“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.”
Elizabeth Robertson, director of research and clinical at Diabetes UK, said: “This is a breakthrough moment, but the next steps are critical. To ensure teplizumab reaches everyone who could benefit, we need it to be made available on the NHS, and the rollout of a screening programme to identify those with early-stage type 1 diabetes.”
Teplizumab is currently under review by the National Institute for Health and Care Excellence for use on the NHS in England and Wales, with draft guidance expected to be published on 26 November 2025.
