Teplizumab has been in clinical trials going back more than 15 years and has a large safety database with ~850 patients with T1D treated across multiple studies.1
1. Data on file. Provention Bio, Inc. 2020. 2. US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for industry, considerations for allogeneic pancreatic islet cell products. https://www.fda.gov/media/77497/download. Accessed August 17, 2020. 3. European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-prevention-diabetes-mellitus_en.pdf. Published January 2018. Accessed May 21, 2020.