Sanofi’s Tzield has received FDA priority review to expand its use to young children with stage 2 type 1 diabetes, aiming to delay progression to clinical disease.
Written By: Pharmacally Medical News Desk
The FDA has accepted Sanofi’s supplemental biologics license application (sBLA) for Tzield (teplizumab-mzwv), granting it priority review for delaying progression to stage 3 type 1 diabetes in children as young as one year old. If approved, Tzield would become the first FDA-approved therapy for this presymptomatic phase in this very young population. The agency’s PDUFA date is April 29, 2026.
Type 1 diabetes progresses long before symptoms appear. By stage 3, insulin-producing beta cells in the pancreas are severely damaged, requiring lifelong insulin therapy. Tzield modulates the immune response to protect remaining beta cells and slow disease progression. Early intervention in children as young as one may preserve more natural insulin production.
Christopher Corsico, Global Head of Development at Sanofi, noted that early intervention could be especially important because the autoimmune attack often begins in early childhood. He emphasized the potential benefit for both families and clinicians managing the disease.
Clinical Evidence: PETITE-T1D Study
The priority review is based on interim one-year data from PETITE-T1D (NCT05757713), an ongoing phase 4, single-arm, open-label, multicentre trial evaluating safety and pharmacokinetics of Tzield in children under eight with stage 2 type 1 diabetes.
Key details:
- 23 children enrolled so far in the interim analysis.
- Participants receive intravenous Tzield once daily for 14 consecutive days.
- Planned follow-up of up to 26 months to assess longer-term safety and outcomes.
Interim findings were presented at the International Society for Pediatric and Adolescent Diabetes annual meeting and published in Diabetologia. Tzield remains unapproved for children under eight; ongoing monitoring continues.
Current Approvals and Global Landscape
Tzield is approved in the United States for adults and children aged eight and older to delay stage 3 type 1 diabetes onset. It has also received approvals in China, the UK, Canada, Israel, Saudi Arabia, the UAE, and Kuwait. In Europe, regulators issued a positive opinion in late 2025, where it will be marketed as Teizeild.
How Tzield Works
Tzield is a CD3-directed monoclonal antibody (a lab-engineered protein targeting T cells). It reduces autoimmune activity against pancreatic beta cells, preserving natural insulin production and delaying clinical diabetes onset.
Type 1 Diabetes Stages
Experts view type 1 diabetes as a continuum with four stages:
- Stage 1: Autoantibodies present; blood glucose normal. No symptoms.
- Stage 2: Autoantibodies persist; blood glucose abnormal. Presymptomatic.
- Stage 3: Clinical diabetes with symptoms like thirst, frequent urination, fatigue, and weight loss.
- Stage 4: Long-standing disease with high complication risk.
Priority Review Implications
Priority review shortens the FDA timeline for therapies addressing serious conditions with potential public health impact. Approval could expand autoantibody screening and early specialist referrals for at-risk children, advancing disease-modifying strategies in type 1 diabetes.
References
Press Release: Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes, 05 January 2026, Press Release: Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes
Teplizumab in Pediatric Stage 2 Type 1 Diabetes (PETITE-T1D), ClinicalTrials.gov ID NCT05757713, https://clinicaltrials.gov/study/NCT05757713
Gitelman SE, et al, Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes. Diabetologia. 2025 Nov 6. doi: 10.1007/s00125-025-06586-1. Epub ahead of print. PMID: 41196293.