New Meds and Tech from the D&T Committee: Teplizumab Approval Expanded to Stage 3 Type 1 Diabetes (Ages 8-17)
Prepared on behalf of PES Drugs and Therapeutics Committee by Neha Patel, DO.
Teplizumab (Tzield™), a humanized anti–CD3 monoclonal antibody, is a disease-modifying therapy targeting the autoimmune process in type 1 diabetes (T1D). It was initially approved by the FDA in November 2022 for individuals ≥8 years of age with stage 2 T1D,1 and now has received accelerated approval for use in stage 3 T1D in patients aged 8–17 years.2-3
The phase 3 PROTECT trial was a randomized, double-blind, placebo-controlled multinational study that enrolled 328 youth (teplizumab n=217, placebo n=111) within 6 weeks of stage 3 T1D diagnosis. Participants received two 12-day infusion courses (baseline and at 26 weeks), in addition to standard diabetes care.4
The PROTECT trial demonstrated that teplizumab significantly preserved beta‑cell function compared with placebo, as measured by stimulated C-peptide levels at 78 weeks. This preservation is clinically meaningful, as it is associated with improved glycemic outcomes, reduced insulin requirements, and lower risk of hypoglycemia and long-term complications. The safety profile in stage 3 T1D is consistent with prior experience in stage 2 T1D, with generally manageable, transient adverse events4.
Treatment must be initiated within 8 weeks of diagnosis in patients with ≥1 positive islet autoantibody and preserved beta-cell function (peak C-peptide >0.2 pmol/mL) via a mixed meal tolerance test or alternative method,5 i.e., 90-minute post-meal stimulated C-peptide.
References:
- Lledó-Delgado A, Preston-Hurlburt P, Currie S, et al. Teplizumab induces persistent changes in the antigen-specific repertoire in individuals at risk for type 1 diabetes Clin Invest. Aug 132024;134(18)doi:10.1172/jci177492
- FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes. Updated 06/15/2026. Accessed 06/15/2026, https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-tzield-teplizumab-certain-pediatric-patients-recently-diagnosed-stage-3
- Press Release: Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes. Updated 06/12/2026. Accessed 06/15/2026, https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-12-22-09-58-3311349
- Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes. The New England Journal of Medicine. Oct 18, 2023; 289:2151-2161.
- Tzield prescribing drug insert. Final 6.12.26 Tzield Accelerated Approval (S-010) and CMC Supplement Approval (S-014).pdf. http://products.sanofi.us/tzield/tzield.pdf