Sanofi’s Tzield approved in the US to delay onset of stage 3 type 1 diabetes in young children

The FDA has recently approved an expanded indication for Sanofi’s Tzield (teplizumab-mzwv), extending its use to children as young as one year of age to delay the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2. Previously approved for patients aged eight and older, Tzield is now the first disease-modifying therapy available for this youngest patient population. The approval was granted under priority review and is supported by one-year data from the PETITE-T1D Phase 4 study evaluating safety and pharmacokinetics in young children.

Kimber Simmons, Associate Professor of Pediatrics at the Barbara Davis Center in Colorado, highlighted the particular urgency of early intervention in this age group: “These children are often at the highest risk of progressing quickly and without warning. Delaying the onset of stage 3 type 1 diabetes during the years when management is often most difficult because of a child’s small size and dependence on caregivers could have a truly meaningful impact for families.”

Christopher Corsico, Global Head of Development at Sanofi, underlined the immunological rationale behind the expanded approval: “The autoimmune attack driving this disease often begins early in life. This approval underscores the importance of targeting the immune system early in autoimmune type 1 diabetes, aiming to impact its natural progression by delaying the loss of insulin production in the pancreas.”

Tzield is also under FDA review for a potential indication to delay progression of stage 3 type 1 diabetes in patients aged eight and older recently diagnosed with stage 3. The therapy is already approved in the EU, UK, China, Canada, Israel, Saudi Arabia, the UAE, Kuwait and Brazil for adults and paediatric patients aged eight and older with stage 2 type 1 diabetes.

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Related Topics and Keywords

Diabetes, Sanofi’s Tzield, stage 3 diabetes, type 1 diabetes, tzield