Sanofi’s Tzield (teplizumab) has received expanded approved from the US FDA, allowing it to be used for children aged one year and older with stage 2 type 1 diabetes (T1D) to delay progression to stage 3 disease.
The decision extends the therapy’s previous approval, which covered patients aged eight years and above, and was granted under a priority review. It is supported by one-year data from the phase 4 PETITE-T1D study, which assessed safety and pharmacokinetics in younger children.
Tzield is a CD3-directed monoclonal antibody and is described as a disease-modifying therapy designed to delay the onset of clinical T1D by targeting the autoimmune process that destroys insulin-producing beta cells.
Associate Professor of Pediatrics at the Barbara Davis Center, Kimber Simmons said: “This approval opens an important new chapter in diabetes care for young children with stage 2 type 1 diabetes and their families. This is especially important because these children are often at the highest risk of progressing quickly and without warning.”
The PETITE-T1D study is an open-label, single-arm phase 4 trial involving 23 participants under the age of eight with stage 2 T1D. Patients received daily intravenous infusions of Tzield for 14 consecutive days, with follow-up extending up to 26 months.
Stage 2 T1D is characterised by the presence of two or more diabetes-related autoantibodies alongside dysglycaemia, reflecting ongoing autoimmune destruction of beta cells. Progression to stage 3 marks the onset of clinical disease, requiring lifelong insulin therapy.
Christopher Corsico, Global Head of Development at Sanofi, said the approval “underscores the importance of targeting the immune system early in autoimmune type 1 diabetes, aiming to impact its natural progression”.
Tzield was first approved in the US in 2022 for delaying the onset of stage 3 T1D in adults and children aged eight years and older with stage 2 disease. It has since been authorised in multiple regions, including the EU, UK and China, for the same indication.
Sanofi said the therapy is also under FDA review for a potential additional indication in patients aged eight years and older recently diagnosed with stage 3 T1D.
Type 1 diabetes is a progressive autoimmune condition in which immune-mediated destruction of pancreatic beta cells leads to loss of insulin production. Early intervention to delay disease progression is seen as a potential way to reduce the burden of disease management, particularly in very young children.