The US Food and Drug Administration (FDA) has granted accelerated approval to Sanofi’s Tzield (teplizumab-mzwv) for children aged eight to 17 years who have recently been diagnosed with stage 3 type 1 diabetes (T1D). The decision allows the therapy to be used to delay the decline in endogenous insulin production and marks the first disease-modifying treatment approved in the United States for patients at this stage of the disease. The Tzield FDA Approval applies specifically to autoimmune stage 3 T1D and does not extend to non-autoimmune dysglycemic conditions.
Commenting on the approval, Aaron J. Kowalski, PhD, CEO of Breakthrough T1D, said: “We now have a novel therapy that targets the autoimmune and progressive nature of stage 3 type 1 diabetes.” He added, “Approximately 64,000 people are diagnosed with T1D every year. We are excited that the approval of Tzield in this indication provides a treatment option for certain patients diagnosed in stage 3 T1D, which is when many start experiencing common symptoms of the disease.”
The FDA’s decision was supported by findings from the PROTECT phase 3 study (NCT03875729) and additional evidence from Sanofi’s broader clinical development program involving more than 900 patients treated with Tzield. Results from the study showed a significant slowing in the decline of beta cell function, measured through mean C-peptide levels following a four-hour mixed-meal tolerance test, compared with placebo. Safety observations in the trial were consistent with previous studies. The most frequently reported adverse reactions included lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase and headache. Serious events, including cytokine release syndrome and life-threatening viral reactivation, have also been reported, with immunocompromised patients considered at greater risk.
The approval was issued through the FDA’s accelerated approval pathway, based on evidence showing reduced C-peptide decline. Continued approval may depend on confirmation of clinical benefit in future studies. To support this requirement, the BETA-PRESERVE phase 3 study (NCT07088068) has already begun enrolling participants. Christopher Corsico, Global Head of Development, Sanofi, said: “We welcome this accelerated approval by the FDA, which recognizes the potential of Tzield to delay the progression of recently diagnosed stage 3 T1D in children aged eight to 17 years.” He added, “Tzield will now offer a new pathway in the treatment paradigm of stage 3 T1D, one that we hope will further enable healthcare providers in the US to take a more proactive approach to disrupt the underlying autoimmune attack against insulin-producing beta cells.” Prior to the Tzield FDA Approval for recently diagnosed stage 3 T1D, the FDA expanded the medicine’s indication in April 2026 to include children aged one year and above with stage 2 T1D.
