MHRA backing of Sanofi’s teplizumab heralds new era for type 1 diabetes

French pharma major Sanofi (Euronext: SAN) late yesterday announced that teplizumab, a humanized anti-CD3 monoclonal antibody, the first of an emerging class of disease modifying treatments, has been authorized by the UK’s Medicines and Healthcare Regulatory Agency (MHRA).

It has been licenced to delay the onset of symptomatic Stage 3 autoimmune type 1 diabetes (T1D) in adult and pediatric patients eight years of age and older with Stage 2 T1D.  Following approval in the USA, the UK is the first country in Europe to be granted a licence. Until now, available options have focused solely on managing the symptomatic disease.

Sanofi picked up rights to teplizumab, which is marketed as Tzield in the USA, as part of its  $2.9 billion acquisition of Provention Bio in 2023. The drug generated sales of 54 million euros ($63.3 million) in 2024, a year-on-year rise of 116%.