FDA expands teplizumab indication to children and adolescents with newly diagnosed type 1 diabetes
The accelerated approval authorizes the first disease-modifying therapy intended to slow the loss of endogenous insulin production after the clinical diagnosis of type 1 diabetes.
Rafael Mantovani
5 min read
June 23, 2026
Sources
- 1. U.S. Food and Drug Administration. FDA approves new indication for Tzield (teplizumab) for certain pediatric patients with recently diagnosed stage 3 type 1 diabetes [Internet]. Silver Spring (MD): FDA; 2026 Jun 15 [cited 2026 Jun 23]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-tzield-teplizumab-certain-pediatric-patients-recently-diagnosed-stage-3
- 2. Ramos EL, Dayan CM, Chatenoud L, Sumnik Z, Simmons KM, Szypowska A, et al. Teplizumab and β-cell function in newly diagnosed type 1 diabetes. N Engl J Med. 2023;389(23):2151-61. doi:10.1056/NEJMoa2308743.
- 3. National Library of Medicine (US). Recent-onset type 1 diabetes trial evaluating efficacy and safety of teplizumab (PROTECT) [Internet]. Bethesda (MD): ClinicalTrials.gov; 2019 [cited 2026 Jun 23]. ClinicalTrials.gov identifier: NCT03875729. Available from: https://clinicaltrials.gov/study/NCT03875729
Written by
Rafael Mantovani
Pharmacy
Rafael Mantovani holds a Pharmacy degree and a Master’s in Pharmaceutical Sciences from the Federal University of São Paulo (UNIFESP). Over the course of his career, he has built solid expertise in Medical Affairs, working at the intersection of science, strategy, and medical education. His professional focus lies in evidence-based medicine and health technology assessment (HTA), with a strong commitment to translating data into meaningful decisions that benefit both patients and healthcare systems.
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