US EditionPress Release: Sanofi's Tzield Approved in the US to Delay the Onset of Stage 3 Type 1 Diabetes in Young Children
The expanded indication makes Tzield the first disease-modifying therapy for children as young as 1, supported by one-year data from a 23-patient study.
- On Wednesday, April 22, 2026, the U.S. Food and Drug Administration approved Sanofi's Tzield to delay the onset of stage 3 type 1 diabetes in children as young as one year old, expanding the indication from eight years and older.
- Autoimmune type 1 diabetes involves gradual destruction of insulin-producing beta cells, with young children facing the highest risk of rapid disease progression without early medical intervention.
- Data from the PETITE-T1D phase 4 clinical study supported the approval, with 23 participants receiving intravenous infusions for 14 consecutive days to assess safety and pharmacokinetics.
- Christopher Corsico, Global Head of Development at Sanofi, said the "autoimmune attack driving this disease often begins early in life." Dr. Kimber Simmons, Associate Professor of Pediatrics at the Barbara Davis Center in Aurora, Colorado, added the approval "opens an important new chapter."
- Tzield is already approved in the EU, UK, China, Canada, Israel, Saudi Arabia, the UAE, Kuwait, and Brazil for pediatric patients aged eight and older diagnosed with stage 2 T1D.
12 Articles
12 Articles
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The Food and Drug Administration (FDA) approved the use in young children of the Tzield treatment, used to slow the progression of type 1 diabetes, announced on Wednesday the French pharmaceutical giant Sanofi. Until now, the treatment in the country was reserved for adults and children over eight years of age. With the new measure, it will be able to be employed in children over one year of age, according to the AFP.
The United States approved the use in young children of Tzield treatment, used to slow the progression of type 1 diabetes, announced Wednesday the giant...
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