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Home > News & events > News > Teplizumab approved in Europe to delay onset of type 1 diabetes
The approval allows Teizelid to be used in adults and children aged eight years and older to delay progression to stage 3 type 1 diabetes, when insulin therapy becomes necessary. It is the first disease-modifying therapy for type 1 diabetes to be approved in the European Union.
The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is based on results from the TN-10 phase 2 clinical trial. The study showed that teplizumab could delay the onset of stage 3 type 1 diabetes, demonstrating the potential of early intervention to slow disease progression.
In the UK, teplizumab has already been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). However, it is not yet available on the NHS, as it is currently awaiting a decision from the National Institute for Health and Care Excellence (NICE) on whether it should be funded for use.
NICE assesses the clinical and cost effectiveness of new treatments before they can be made widely available through the NHS. Here at Breakthrough T1D, we are continuing to work with NICE to ensure the voices of people affected by T1D are heard throughout this process.
Hilary Nathan, Director of Policy at Breakthrough T1D, said: “This European approval is a powerful moment for everyone affected by type 1 diabetes. It builds on the MHRA’s decision in the UK and reinforces what the T1D community has long been working towards – the ability to intervene earlier and change the course of this condition. While we are still awaiting a funding decision from NICE, we remain determined to see people in the UK gain access to treatments like teplizumab as quickly as possible. Breakthrough T1D will continue to stand alongside the community and push for progress that truly makes a difference to lives.”
Teplizumab is the generic (scientific) name of the medicine. It is an immunotherapy designed to target the immune attack that leads to type 1 diabetes.
While the names differ, all refer to the same therapy.
This approval reflects decades of research funded by organisations including Breakthrough T1D and signals a shift towards earlier diagnosis and intervention in type 1 diabetes.
Breakthrough T1D will continue to advocate for access to disease-modifying therapies, invest in research, and support the type 1 diabetes community as this new era of treatment unfolds.
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