The Medicines and Healthcare products Regulatory Agency (MHRA) has approved teplizumab (Tzield), the UK’s first immunotherapy for type 1 diabetes, to delay the onset of Stage 3 T1D in adults and children aged 8 years and older with Stage 2 T1D. Clinical data show that teplizumab can postpone progression to Stage 3 T1D by an average of three years.
Stage 3 T1D is the point at which patients typically begin experiencing blood sugar issues and are formally diagnosed, requiring lifelong insulin therapy. Teplizumab targets people at Stage 2 T1D, an earlier phase where the risk of progression is high.
The approval was granted under the International Recognition Procedure (IRP), enabling the MHRA to draw on expertise from trusted global regulators while independently reviewing safety and efficacy data.
Teplizumab is administered as a once-daily intravenous infusion for 14 days. The MHRA emphasized that while it can leverage international decisions, it retains full authority to reject applications where evidence is insufficient.
Information on possible side effects will be available in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) on the MHRA website within seven days of approval. The agency confirmed it will continue to closely monitor the medicine’s safety and effectiveness.