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The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved teprizumab (Tzield, Aventis Pharma Limited) as the UK's first immunotherapy for type 1 diabetes (T1D).
The drug is approved for adults and children aged 8 and older with stage 2 T1D, slowing progression to stage 3.
Teprizumab was approved in the US in 2022 by the Food and Drug Administration after clinical trials showed that it could delay the onset of symptomatic T1D in high-risk people at an average of three years, at an early, high-risk, no-symptom stage.
Approximately 8% of diabetics in the UK have T1D, with around 400,000 people. This is the most common type of diabetes among children and young people. The UK is one of the highest rates in Western Europe, with an estimated incidence of 193.8 per 100,000 people in the younger age group.
Slowing progression will protect you from complications
When Stage 3 T1D occurs, people usually begin to experience blood glucose problems and often require lifelong insulin treatment. By slowing progression, patients can maintain insulin treatment, carbohydrate counts, and hypoglycemic episodes for longer. It also helps maintain healthy blood sugar levels and reduces the risk of long-term complications.
Age after diagnosis may mean that the patient can better manage his condition, potentially avoiding childhood onset entirely.
The MHRA said the approval came through international approval procedures. This allows institutions to elicit the expertise and decision-making of trustworthy regulatory partners.
“New Era” for T1D Treatment
Teprizumab addresses the root cause of T1D: an immune system attack on pancreatic beta cells that make insulin. Slowing this attack will protect beta cell function.
Diabetes UK described approval as “a milestone moment and the beginning of a new era of T1D treatment.” The charity said it will continue to lobby the National Institutes of Health (Nice) for the National Institutes of Health (Nice) to recommend drugs for daily NHS use in the UK.
Nice is expected to reconsider the draft decision to not recommend teprizumab when the assessment committee meets in October.
Although approved for early stage T1D only, Diabetes UK says in clinical trials it could benefit newly diagnosed patients by protecting about 20% of remaining beta cells, making it easier to control glucose and reduces long-term risks.
Although T1D cannot be prevented yet, the charity said, coupled with screening for diabetic autoantibodies to identify early-stage people, immunotherapy can provide a way to delay the full development of as much as possible.
Seek for screening
Dr. Elizabeth Robertson, Head of Research and Clinical UK Diabetes, said the next step is important.
“We need to make it available in the NHS to reach everyone who can benefit from Teprizumab, and we also need to deploy a screening program to identify people with early stage T1D,” she said.
Researchers hope that future progress will prolong delays (potentially for life) and lead to treatment for people who already live with T1D.
Treatment and safety
Teprizumab is administered as a daily intravenous infusion for 14 days in a hospital setting.
The most common side effects are rashes, leukopenia, an increased risk of infection, and headaches. The complete list will be published on the MHRA website within 7 days.
The MHRA said it would closely monitor the safety of the drug, urging clinicians and patients to report suspected side effects via the yellow card scheme.
Dr. Sheena Meredith is an established medical writer, editor and consultant at Medical Communications, and has extensive writing for medical professionals and the public. She is qualified in medicine, law and medical ethics.
