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MHRA Licenses Teplizumab to Delay Onset of Type 1 Diabetes

NICE will next assess cost-effectiveness to decide NHS funding for the 14-day immunotherapy

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Sanofi's disease-modifying type 1 diabetes drug, Tzield, has been approved by the MHRA. Image credit: VCG / Contributor, Visual China Group via Getty Images.
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Overview

  • The MHRA authorized teplizumab for people aged eight and older with stage two type 1 diabetes, making the UK the first European country to license a disease-modifying immunotherapy for this stage.
  • Trials show that a 14-day regimen of daily intravenous infusions can delay progression to clinical (stage three) type 1 diabetes by about three years.
  • The National Institute for Health and Care Excellence will assess teplizumab’s cost-effectiveness next, determining whether it will be available on the NHS or only through private channels.
  • Successful rollout depends on establishing autoantibody screening programmes and expanding infusion-service capacity to identify eligible patients and deliver the therapy.
  • Charities including Diabetes UK and Breakthrough T1D have hailed the licence as a major advance and are pressing for swift NHS approval and infrastructure planning.