Sanofi：TZIELD®teplizumab Gets U.S. Label Expansion Approval
On June 12 local time, Sanofi announced that the U.S. FDA has granted accelerated approval for Tzield (teplizumab-mzwv) to delay the decline in endogenous insulin secretion in children aged 8 to 17 years recently diagnosed with Stage 3 type 1 diabetes (T1D).
Teplizumab is a monoclonal antibody targeting the CD3 antigen on the surface of T cells. By binding to CD3 on effector T cells, it inhibits T cell attack on pancreatic beta cells, thereby protecting them from destruction. In March 2023, Sanofi acquired Provention Bio for $2.9 billion, gaining this drug. It is the world’s first therapy that can delay the onset of type 1 diabetes, initially approved by the FDA in November 2022. In April 2026, the FDA expanded its indication to include children aged 1 year and older for delaying the progression from Stage 2 T1D to Stage 3 T1D in adults and children aged 8 years and older. Additionally, the drug is approved for delaying progression from Stage 2 T1D to Stage 3 T1D in the UK, European Union (under the brand name Teizeild), China, Australia, Canada, Israel, Saudi Arabia, UAE, Kuwait, Brazil, and Switzerland.
This approval was supported by data from the PROTECT Phase 3 study (NCT03875729). PROTECT was a randomized, double-blind, placebo-controlled global multicenter Phase 3 clinical trial enrolling 328 children and adolescents aged 8 to 17 years who had been diagnosed with clinical Stage 3 T1D within the prior six weeks; subjects were randomized 2:1 to Tzield or placebo. Participants received a first course of daily infusions for 12 consecutive days after randomization, followed by a second course 26 weeks later, also daily for 12 consecutive days. All participants received standard-of-care medications as needed. The study assessed beta-cell function. At the end of the study, compared with the placebo group, Tzield significantly slowed the decline in mean C-peptide levels (area under the curve after a 4-hour mixed meal tolerance test; least squares mean difference of 0.13 pmol/mL; 95% CI: 0.09–0.17; p < 0.001). Broader clinical development program data, which included over 900 patients treated with Tzield, also supported the approval.
Adverse events observed in the PROTECT Phase 3 study were consistent with previous studies. The most common adverse reactions included lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, elevated liver transaminases, and headache. Serious events including cytokine release syndrome and life-threatening cases of viral reactivation have been reported with Tzield use. Immunocompromised patients are at increased risk of viral reactivation.
This indication was granted accelerated approval based on evidence of slowing C-peptide decline. Continued approval for this indication may depend on verification and description of clinical benefit in confirmatory studies. A confirmatory Phase 3 study, BETA-PRESERVE (NCT07088068), has been initiated and is currently recruiting participants.
Buy TZIELD®（teplizumab） from China and save up to 80% on costs . no insurance needed . compare prices from a certified HongKong pharmacy .with fast shipping. Contact us now on WhatsApp to get the latest prices.
