FDA Clears Sanofi’s Tzield as First Disease-Modifying Therapy for Stage 3 Type 1 Diabetes | iPharmaCenter

Sanofi has secured US regulatory clearance for Tzield as a treatment aimed at modifying disease progression in children recently diagnosed with stage 3 type 1 diabetes. The authorization marks the first time a therapy has been approved in this setting to help preserve the body’s own insulin production.

The US Food and Drug Administration granted accelerated approval for Tzield for use in patients aged 8 to 17 years who have been newly diagnosed with stage 3 type 1 diabetes. The therapy is intended to slow the loss of endogenous insulin secretion. It is not indicated for individuals with dysglycemia that is not driven by autoimmune mechanisms.

The decision is supported by findings from the Phase 3 Protect study along with broader clinical evidence involving more than 900 individuals treated with Tzield. In the Protect trial, the therapy demonstrated a meaningful reduction in the rate of decline in beta cell function compared with placebo, as measured by C peptide levels during a mixed meal tolerance test. Safety outcomes observed in the trial were aligned with previously reported data.

Study overview

The Protect study was a global, randomized, double blind, placebo controlled Phase 3 trial that enrolled 328 pediatric and adolescent patients aged 8 to 17 years. All participants had received a diagnosis of stage 3 type 1 diabetes within six weeks prior to enrollment. Patients were assigned to receive either Tzield or placebo in a 2 to 1 ratio.

Treatment consisted of two courses of daily intravenous infusions lasting 12 days each. The second course was administered approximately six months after the first. Standard diabetes care was continued for all participants throughout the study period.

Tzield Therapy background and its mechanism of action

Tzield, also known as teplizumab, is a monoclonal antibody that targets CD3 on T cells. It represents a new approach in type 1 diabetes by addressing the underlying autoimmune process rather than focusing solely on glucose control.

The therapy was first cleared in the United States in November 2022 to delay progression to stage 3 disease in individuals aged 8 years and older with stage 2 type 1 diabetes. In April 2026, the indication was expanded to include patients as young as one year of age.

Outside the US, Tzield has also received approvals in multiple regions for delaying progression to stage 3 disease in patients with stage 2 type 1 diabetes, including in Europe, the United Kingdom, China, Australia, Canada, and several countries in the Middle East and Latin America. Additional regulatory reviews are currently underway in other markets.