On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ages 8 through 17 years who have been recently diagnosed with Stage 3 type 1 diabetes (T1D).
First disease modifying therapy approval for new onset stage 3 diabetes represents a significant milestone for the pediatric type 1 diabetes community
On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ages 8 through 17 years who have been recently diagnosed with Stage 3 type 1 diabetes (T1D). This approval marks the first FDA-approved treatment for this indication and represents an important advancement for children living with type 1 diabetes and their families.
"The FDA recognizes the large unmet need in patients with type 1 diabetes," said Acting Associate Director for Therapeutic Review of the Division of Diabetes, Lipid Disorders and Obesity, Mahtab Niyyati M.D. "Based on robust evidence of safety and effectiveness, this accelerated approval provides a chance for pediatric patients with recently diagnosed Stage 3 type 1 diabetes to alter the course of their disease."
Tzield was previously approved to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 1 year of age and older with Stage 2 type 1 diabetes. The newly approved indication is for the use of Tzield to help delay the decline in insulin production in certain pediatric patients who have recently been diagnosed with Stage 3 disease.
The FDA granted this application under the agency's accelerated approval pathway. The approval was based on evidence from an adequate and well-controlled clinical trial that Tzield demonstrated a statistically significant effect on C-peptide, a surrogate endpoint reasonably likely to predict a clinical benefit. A required postapproval study is ongoing to verify clinical benefit.
Healthcare professionals and patients should review the prescribing information for important safety information. The approved labeling includes a boxed warning regarding serious and life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation, reported with Tzield. The most common side effects of the drug are vomiting, rash, increased liver transaminase (a blood test that detects liver stress or damage) and headache. Tzield is associated with a reduction in white blood cells (leukopenia), including a reduction in different types of white blood cells (lymphopenia and neutropenia) that can increase the risk for certain infections. More information: FDA Approves Drug for Pediatric Stage 3 Type I Diabetes .
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.