MHRA approves immunotherapy which delays development of type 1 diabetes
An immunotherapy for type 1 diabetes has been approved for use in the UK, in a move which could mark a ‘turning point’ in treatment of the condition if eligible patients could be identified.
The Medicines and Healthcare products Regulatory Agency (MHRA) said teplizumab, also known as Tzield, is safe and effective at delaying the development of type 1 diabetes for people in the early stages of the condition.
Trials have shown the treatment can delay the onset of stage 3 type 1 diabetes by an average of three years in adults and children over the age of eight years.
The treatment is for people at stage 2 where beta cell function is declining and blood sugar levels have become abnormal. Patients would also have two or more diabetes related autoantibodies but no symptoms yet.
It will be the UK’s first ever approved immunotherapy for type 1 diabetes, the MHRA said.
Teplizumab is administered via intravenous infusion once daily for 14 days.
Approval was given through the International Recognition Procedure which allows the MHRA take into account the expertise and decision-making of trusted regulatory partners.
Diabetes UK said it was the beginning of a new era for type 1 diabetes treatment.
Dr Elizabeth Robertson, director of research and clinical at Diabetes UK, said: ‘Today’s landmark licensing of teplizumab in the UK marks a turning point in the treatment of type 1 diabetes.
‘For the first time, we have a medicine that targets the root cause of the condition, offering three precious extra years free from the relentless demands of managing type 1 diabetes.
But she said the next steps would be critical for people in the UK to access it.
‘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.
‘Diabetes UK is leading the charge, driving type 1 diabetes screening initiatives, funding world-class immunotherapy research, and working with the NHS to make sure no one is left behind.’
In the future, the charity wants to see multiple immunotherapies available to stop type 1 diabetes in its tracks, at its earliest stages and beyond, she added.
The charity said NICE must now review teplizumab’s cost-effectiveness to the NHS, and make recommendations about which patient groups should have access to it.
And for teplizumab to reach the people who could benefit from it, there also needs to be screening initiatives in place to identify people in the early, symptomless stages of type 1 diabetes, it said.
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