Breakthrough T1D Celebrates Approval of Tzield for Use in Stage 3 Type 1 Diabetes in the US
The approval is based on phase 3 data showing Tzield slowed beta-cell decline in 328 children and adolescents, Sanofi said.
- On Friday, the U.S. Food and Drug Administration granted accelerated approval to Tzield for individuals aged 8-17 within eight weeks of a stage 3 type 1 diabetes diagnosis.
- This decision marks the first regulatory approval of a disease-modifying therapy for stage 3, targeting the autoimmune nature of the disease rather than just managing symptoms.
- Data from the PROTECT phase 3 study supported approval, demonstrating that Tzield significantly slowed the decrease in mean C-peptide levels compared to placebo.
- "We now have a novel therapy that targets the autoimmune and progressive nature," said Aaron J. Kowalski, Ph.D., Breakthrough T1D CEO, praising the milestone.
- Sanofi is continuing to study Tzield through the confirmatory BETA-PRESERVE study, which will provide additional data in the coming years on long-term effectiveness.
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Breakthrough T1D Celebrates Approval of Tzield for use in Stage 3 Type 1 Diabetes in the US
NEW YORK, June 12, 2026 /PRNewswire/ -- Breakthrough T1D, the leading global type 1 diabetes (T1D) research and advocacy organization, applauds today's decision from the U.S. Food and Drug Administration (FDA) to approve Tzield for use in individuals ages 8-17…
Press Release: Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients rec
Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes Accelerated approval in children aged eight to 17 years old recently diagnosed with stage 3 T1D to delay the decline in endogenous insulin production Approval based on the PROTECT phase 3 study and additional data from the global clinical development program from over 900 patients who received Tzield Paris, June…
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