MHRA approves licencing for teplizumab to be used in the UK

Breakthrough T1D UK played a key role in funding early-stage research into teplizumab and facilitating regulatory pathways. This breakthrough treatment is the first of its kind to delay the onset of clinical type 1 diabetes in people who are in the early stages of the condition, but not yet showing symptoms. It represents a seismic shift in how we think about T1D and its management.  

Karen Addington MBE, Chief Executive of Breakthrough T1D said: “I am personally delighted and welcome the MHRA’s approval of teplizumab. After years of research, clinical trials and drug development, we have an incredible breakthrough. Teplizumab is an immunotherapy that will delay the diagnosis of type 1 diabetes, a relentless and lifelong autoimmune condition. This innovative new therapy can help avoid life-threatening complications at diagnosis like diabetic ketoacidosis (DKA), which is caused by extremely high blood glucose levels. Sadly, many people experience DKA, and some do not recover. Teplizumab not only has the potential to save lives but also to alleviate the financial strain of emergency diagnoses of type 1 diabetes on the NHS.”  

How teplizumab works

Teplizumab is an immunotherapy designed to target the immune system’s attack on insulin-producing beta cells in the pancreas. By modifying the immune response, it can delay the onset of clinical type 1 diabetes in people who are in the early stages of the condition but have not yet shown symptoms.  

In clinical trials, a single course of teplizumab delayed the onset of type 1 diabetes by an average of nearly three years. In some cases, it delayed the condition significantly longer. This window gives people and families precious time to prepare, plan, and potentially benefit from future treatments.  

Delaying T1D

Around 400,000 people in the UK live with type 1 diabetes; a relentless, lifelong condition that requires constant management to stay alive. Without insulin, blood sugar levels can swing dangerously, leading to long-term complications or even life-threatening diabetic ketoacidosis (DKA), which affects one in four children at diagnosis. Teplizumab represents a breakthrough. It can delay the onset of clinical type 1 diabetes, helping to prevent serious DKA episodes and offering precious time before the burden of daily insulin therapy begins. 

Breakthrough T1D funded teplizumab research

Breakthrough T1D was instrumental in the early stages of teplizumab’s development. Over 25 years, the charity helped fund pioneering research that laid the groundwork for this breakthrough therapy. It supported early clinical trials and scientific discovery that demonstrated how teplizumab could delay the onset of T1D by targeting the immune system.  

This early-stage investment was critical in proving the potential of immune intervention in T1D, a concept that was still emerging at the time. That proof-of-concept opened the door for larger trials and pharmaceutical development, ultimately leading to teplizumab gaining its UK licence from MHRA.  

Next Steps: Access on the NHS

On Friday 15 August, the National Institute for Health and Care Excellence (NICE) published draft guidance not to recommend teplizumab for use on the NHS. Draft guidance is not final, and it’s rare for a treatment or technology to receive a positive decision at this first stage. We now have four weeks to respond to the draft guidance before the next NICE committee meeting. 

You will also have the opportunity to share your views with NICE on the draft guidance. 

NICE will issue their final guidance in November 2025.