Sanofi announces FDA label expansion for Tzield in the United States
Sanofi has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for Tzield, extending its indication from children aged 8 and older to include pediatric patients aged 1 year and older.
The treatment is designed to delay the onset of Stage 3 type 1 diabetes (T1D) in patients diagnosed with Stage 2 T1D. This approval was granted under FDA Priority Review and is based on one-year interim data from the ongoing PETITE-T1D Phase 4 study, which evaluates the safety and pharmacokinetics of Tzield in young children.
According to Dr. Kimber Simmons, MS, Associate Professor of Pediatrics at the Barbara Davis Center in Aurora, USA: "This approval opens an important new chapter in diabetes management for young children with Stage 2 type 1 diabetes and their families. This is particularly significant as these children often face the highest risk of rapid and unpredictable progression. Delaying the onset of Stage 3 type 1 diabetes during the years when management is often most challenging due to the child's small size and dependence on caregivers could have a truly meaningful impact for families."
Tzield is also currently under FDA review for a potential indication to slow the progression of Stage 3 T1D in patients aged eight and older who have been recently diagnosed with Stage 3 T1D.
Sanofi is the largest European pharmaceutical group. Net sales by family of products break down as follows:
- pharmaceutical products (81.8%): prescription drugs for the treatment of multiple sclerosis, neurological diseases, inflammatory diseases, autoimmune diseases, rare diseases, cancers and rare hematological diseases;
- human vaccines (18.2%): pediatric vaccines, vaccines for flu, meningitis, and polio, booster vaccines, and vaccines for travelers and endemic areas.
At the end of 2025, the group had 37 production sites worldwide.
Net sales are distributed geographically as follows: France (3.9%), Europe (17.1%), the United States (50.8%), China (6%) and other (22.2%).
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