PARIS, France, June 13, 2026
Sanofi has achieved a major breakthrough in diabetes care after the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tzield® (teplizumab-mzwv) for children aged 8 to 17 years recently diagnosed with Stage 3 Type 1 Diabetes (T1D). The approval makes Tzield the first disease-modifying therapy approved for patients with newly diagnosed Stage 3 T1D, representing a transformative shift in how the autoimmune disease may be managed. Unlike conventional treatment approaches that focus primarily on insulin replacement and symptom control, Tzield targets the underlying autoimmune process responsible for the destruction of insulin-producing beta cells. The decision expands Sanofi’s leadership in Type 1 Diabetes innovation and offers physicians a new opportunity to preserve pancreatic function during the critical early stages following diagnosis. The approval was supported by findings from the pivotal Phase 3 PROTECT study and additional clinical data from more than 900 patients treated with Tzield across the global development program.
PROTECT Phase 3 Trial Demonstrates Significant Beta Cell Preservation
The FDA’s accelerated approval was based on positive results from the PROTECT Phase 3 clinical trial, which evaluated Tzield in children and adolescents diagnosed with Stage 3 Type 1 Diabetes within six weeks of diagnosis. The randomized, double-blind, placebo-controlled study enrolled 328 patients and assessed preservation of beta-cell function using C-peptide levels, a key indicator of endogenous insulin production. Results demonstrated that Tzield significantly slowed the decline in C-peptide levels compared with placebo, highlighting its ability to preserve insulin-producing cells and potentially delay disease progression.
Preservation of beta-cell function remains one of the most important goals in Type 1 Diabetes management because it may help improve glycemic control, reduce insulin requirements, and lessen the burden of long-term complications. The findings reinforce growing scientific evidence that early intervention targeting autoimmune mechanisms can provide meaningful clinical benefits beyond traditional insulin therapy alone.
First Disease-Modifying Therapy Reshapes T1D Treatment Landscape
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Type 1 Diabetes affects millions of individuals globally and is characterized by an autoimmune attack against pancreatic beta cells, ultimately resulting in complete dependence on insulin therapy. Stage 3 disease marks the onset of clinical diabetes symptoms, including hyperglycemia, excessive thirst, frequent urination, weight loss, fatigue, and blurred vision. Until now, treatment options have focused on replacing lost insulin rather than preserving remaining beta-cell function. The approval of Tzield establishes a new treatment paradigm by offering physicians a therapy designed to intervene directly in the disease process.
Healthcare experts believe this milestone could accelerate research into additional disease-modifying therapies and support broader adoption of biomarker-driven treatment strategies. The approval also reinforces the importance of C-peptide preservation as a clinically meaningful endpoint in future Type 1 Diabetes drug development programs.
Regulatory Milestone Strengthens Sanofi’s Autoimmune Disease Portfolio
The latest approval builds upon Tzield’s previous regulatory successes. Initially approved in the United States in 2022 for delaying the onset of Stage 3 Type 1 Diabetes in patients with Stage 2 disease, the therapy has since received approvals across multiple international markets. The FDA recently expanded its Stage 2 indication to include children as young as one year old, further broadening access to disease-modifying treatment. Continued approval of the newly granted Stage 3 indication will depend on confirmation of clinical benefit through the ongoing BETA-PRESERVE Phase 3 study, which is currently enrolling participants.
As the first therapy capable of modifying disease progression in newly diagnosed Stage 3 Type 1 Diabetes patients, Tzield represents a significant advancement in autoimmune disease treatment and underscores Sanofi’s commitment to developing innovative therapies that address critical unmet medical needs in endocrinology and immunology.
Source: Sanofi press release
