Sanofi Granted FDA Priority Review to Expand Tzield to Young Children
The U.S. Food and Drug Administration has agreed to prioritize a request to expand the use of Tzield to children as young as one year old, currently approved for eight years and older, to delay the onset of stage 3 type 1 diabetes. A decision is expected by April 29, 2026, according to the company.
FDA Reviews Extended Use of Tzield for Younger Children
The U.S. health authority is reviewing an additional biological license application for Tzield (teplizumab-mzwv) aimed at lowering the minimum age of use from eight years to one year, Sanofi announced in its press release. The medication is designed to delay the progression to stage 3 type 1 diabetes in patients diagnosed at stage 2 of the disease. The application is supported by one-year interim data from the phase 4 PETITE-T1D study, which involved 23 participants and assessed the safety and pharmacokinetics of the treatment in young children. These results were presented at the 51st annual conference of the International Society for Pediatric and Adolescent Diabetes and simultaneously published in the journal Diabetologia. The company noted that the safety and efficacy of Tzield in this population have not been approved by any regulatory authority at this stage.
Tzield: A Novel Monoclonal Antibody for Type 1 Diabetes
Tzield is a monoclonal antibody targeting CD3, introduced by Sanofi as the first and only disease-modifying treatment for autoimmune type 1 diabetes. The drug was first approved in the United States in November 2022 to delay the onset of stage 3 type 1 diabetes in adults and children aged eight years and older diagnosed at stage 2. Since then, approvals have been obtained in China, the United Kingdom, Canada, Israel, Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication, according to the press release. In November 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive recommendation for this population, with the product to be marketed under the name Teizeild in the European Union. Additional regulatory reviews are ongoing in various jurisdictions.
Understanding Type 1 Diabetes
Type 1 diabetes is a progressive autoimmune disease in which the immune system gradually destroys the insulin-producing beta cells, affecting the body's ability to regulate blood sugar levels. Stage 2 of the disease is defined by the presence of at least two autoantibodies and dysglycemias related to type 1 diabetes, the press release explains. Christopher Corsico, global head of development at Sanofi, emphasized in the document that the autoimmune attack responsible for this disease begins early in life. The treatment consists of a daily intravenous infusion for 14 consecutive days. The priority review granted by the FDA concerns applications for treatments that are likely to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
