The U.S. Food and Drug Administration has granted accelerated approval to Sanofi SA’s (NASDAQ:SNY) Tzield (teplizumab-mzwv) to delay the decline of endogenous insulin production in children ages 8 to 17 who have been recently diagnosed with stage 3 type 1 diabetes (T1D).
The decision expands the therapy's use in pediatric patients and was supported by data from the Phase 3 PROTECT study.
PROTECT Trial Showed Slower Decline In Beta Cell Function
The FDA based its decision on results from the PROTECT study, which assessed beta-cell function using C-peptide levels measured during a mixed-meal tolerance test.
Tzield significantly slowed the decline in C-peptide levels versus placebo, with a least-squares mean difference of 0.13 pmol/mL (95% CI: 0.09–0.17; p<0.001) at the end of the study.
The agency also reviewed data from more than 900 patients treated with Tzield across its clinical development program. Safety results from PROTECT were consistent with findings from earlier trials.
Confirmatory Study Underway
The approval was granted under the FDA's accelerated approval pathway, which allows medicines for serious conditions with unmet medical needs to reach patients based on surrogate endpoints that are reasonably likely to predict clinical benefit.
Continued approval may depend on verification of clinical benefit in future confirmatory studies.
To support that requirement, the Phase 3 BETA-PRESERVE study is currently enrolling participants.
Builds On Earlier Label Expansion
The latest approval follows an FDA label expansion in April 2026 that broadened Tzield's use for delaying the onset of stage 3 T1D in patients with stage 2 disease, extending eligibility to children as young as 1 year old.
Tzield is also approved in several international markets.
SNY Stock Price Activity: Sanofi shares were down 0.97% at $43.82 at the time of publication on Monday, according to Benzinga Pro data.
Image via Shutterstock
Login to comment