The US FDA has expanded approval of Tzield (teplizumab-mzwv) to children as young as one year to delay progression to stage 3 type 1 diabetes, supported by phase 4 PETITE-T1D data.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
The US Food and Drug Administration has approved a supplemental biologics license application for Tzield (teplizumab-mzwv), expanding its indication to include children as young as one year to delay the onset of stage 3 type 1 diabetes (T1D) in patients with stage 2 disease.
Previously authorized for patients aged eight years and older, the expanded approval was granted under priority review and is supported by one-year data from the phase 4 PETITE-T1D study (NCT05757713), which assessed safety and pharmacokinetics in younger children.
Stage 2 T1D is defined by the presence of multiple diabetes-related autoantibodies along with dysglycemia, reflecting progressive loss of insulin-producing beta cells.
Delaying progression to stage 3, when clinical symptoms emerge and insulin therapy becomes necessary, remains a key objective in disease management.
Kimber Simmons MD, MS, Associate Professor of Pediatrics at the Barbara Davis Center, indicated that younger children often face a higher risk of rapid and unpredictable progression, and that delaying disease onset during early childhood when management is particularly complex could significantly reduce the burden on patients and caregivers.
Tzield is a CD3-directed monoclonal antibody that targets the immune-mediated destruction of pancreatic beta cells and is marketed as the first disease-modifying therapy for T1D.
Christopher Corsico Global Head of Development at Sanofi noted that autoimmune activity in T1D often begins early in life and that early immune intervention may help preserve insulin production and alter disease progression.
The PETITE-T1D trial is a 2-year, single-arm, open-label, multicenter study involving 23 children under eight years of age with stage 2 T1D, evaluating a regimen of once-daily intravenous infusions for 14 consecutive days, with follow-up extending up to 26 months.
Tzield was first approved in the US in November 2022 for patients aged eight years and older with stage 2 T1D and has since been authorized in the UK, China, Canada, Israel, Saudi Arabia, the UAE, Kuwait, and Brazil for similar indications.
Sanofi has also advanced the global regulatory pathway for Tzield (marketed as Teizeild in some regions), securing European Union approval to delay progression to stage 3 type 1 diabetes in patients with stage 2 disease, while also obtaining priority review designation from the US Food and Drug Administration for an expanded indication in children as young as one year at risk of developing clinical disease.
The therapy is also under FDA review for a potential indication in patients recently diagnosed with stage 3 T1D.
Reference
Study Details | NCT05757713 | Teplizumab in Pediatric Stage 2 Type 1 Diabetes | ClinicalTrials.gov
About the Writer
Nikita Jha, BPharm a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.