The US Food and Drug Administration approved expanded use of Sanofi’s Tzield injection for children aged 8 to 17 recently diagnosed with stage 3 type 1 diabetes, the regulator said Friday.
The latest Tzield FDA approval allows the drug to be used to slow the loss of insulin production in newly diagnosed stage 3 patients, as announced by the FDA on June 13.
Tzield, also known as teplizumab-mzwv, was first approved in 2022 to delay progression from stage 2 to stage 3 type 1 diabetes in patients aged 8 years and older. Sanofi said the FDA expanded that earlier-stage indication in April 2026 to include children as young as 1 year old.
Type 1 diabetes is a chronic condition in which the pancreas makes little or no insulin. Stage 3 patients can develop symptoms including frequent urination, excessive thirst and fatigue, and usually need insulin therapy.
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Tzield targets the immune response that damages insulin-producing cells in the pancreas. Sanofi said the stage 3 approval was based on the PROTECT phase 3 study and additional clinical development data.
The study included 328 children and teenagers diagnosed within the past six weeks. Patients who received Tzield had a smaller decline in insulin-producing cell function than placebo recipients after about 18 months.
The drug carries a boxed warning, the FDA’s most prominent safety warning, after reports of serious life-threatening viral infections, including Epstein-Barr virus and cytomegalovirus.
