Sanofi has received approval from the US Food and Drug Administration (FDA) for a supplemental biologic licence application for Tzield (teplizumab-mzwv), allowing its use to delay stage 3 type 1 diabetes (T1D) onset in children as young as one year diagnosed with stage 2 T1D.

The approval expands the previous indication from those aged eight and above and was granted under a priority review process.

This decision is supported by one-year data from the PETITE-T1D Phase IV study, which evaluated the safety and pharmacokinetics of Tzield in children under eight years old.

Additionally, the FDA is reviewing Tzield for use in patients eight years and above recently diagnosed with stage 3 T1D to delay disease progression. Regulatory review processes for Tzield are ongoing in other markets.

The therapy is currently approved in Brazil, Canada, China, the European Union (EU), Israel, Kuwait, Saudi Arabia, the United Arab Emirates, and the UK.

Earlier, the FDA granted Tzield breakthrough therapy and orphan drug designations.

The PETITE-T1D Phase IV trial is a single-arm, non-randomised, open-label, multi-centre study involving 23 participants. It assessed Tzield’s safety and pharmacokinetics in children under eight years with stage 2 T1D.

Participants received daily intravenous infusions for 14 days. The total study duration, including screening, treatment, and follow up, may last up to 26 months.

T1D is a progressive autoimmune disease advancing through four stages, culminating in destruction of insulin-producing beta cells.

Sanofi development global head Christopher Corsico said: “The autoimmune attack driving this disease often begins early in life, and the burden that autoimmune T1D poses in this very young population and their families is significant. “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.”