Sanofi (SNY) announced that the U.S. FDA has approved Tzield for use in children as young as one year old with stage 2 type 1 diabetes, expanding access to a therapy that can delay the onset of stage 3 disease. This marks a significant milestone in pediatric diabetes care, as Tzield was previously approved only for patients aged eight years and older.
Type 1 diabetes is a progressive autoimmune condition in which the immune system destroys insulin-producing beta cells. Children with stage 2 disease already show abnormal blood sugar levels and autoantibodies, placing them at high risk of advancing to stage 3, which requires lifelong insulin therapy. By slowing this progression, Tzield offers families more time before the burdens of full-scale diabetes management begin.
Tzield is a CD3- directed monoclonal antibody administered intravenously once daily for 14 consecutive days. The FDA's expanded approval was supported by the PETITE-T1D Phase 4 study, which confirmed the drug's safety and pharmacokinetics in children under eight years old.
Originally approved in November 2022, Tzield became the first therapy to delay stage 3 type 1 diabetes in stage 2 patients. Beyond the U.S., it is approved in the EU, UK, China, Canada, Israel, Saudi Arabia, UAE, Kuwait, and Brazil for adults and children aged eight and older. The FDA is also reviewing its use in patients newly diagnosed with stage 3 type 1 diabetes.
This approval was granted without warning.
Sanofi, which acquired Tzield through Provention Bio, Inc. continues to expand its immunology pipeline with a focus on early intervention in autoimmune diseases.The company has announced that it will release its Q1 2026 results tomorrow, April 23, 2026, at 7:00 AM EDT.
SNY has traded between $43.32 and $55.73 over the past year. The stock closed Tuesday's trading at $47.13, down 1.79%. In pre-market trading the stock is at $47.19, up 0.13%.
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