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Approval of teplizumab: implications for patients

Type 1 diabetes mellitus (T1DM) can be predicted, and immune therapy can alter the progression of the disease. The FDA’s approval of teplizumab as the first disease-modifying therapy for T1DM and the first therapy aimed at delaying the clinical onset of any immune-mediated disease represents a paradigm shift in the treatment of T1DM.

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Acknowledgements

The Teplizumab Prevention Trial was conducted by the NIH-funded TrialNet research network. We acknowledge the network research teams and clinical trial participants.

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Correspondence to Carla J. Greenbaum.

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Competing interests

C.J.G. and C.S. participate in and receive funding as a clinical site for industry-sponsored or investigator-initiated trials of disease-modifying therapies. In the past 2 years, this has included ProventionBio, Sanofi, BMS, Janssen and Takeda. C.J.G. is a current member of, and previous Chair of, NIH-funded Diabetes TrialNet, which conducted the clinical trial that led to approval. C.S. is also a member of Diabetes TrialNet. C.J.G. is also a member of the NIH-sponsored Immune Tolerance Network, which conducts trials of disease-modifying therapies.

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TrialNet: https://www.trialnet.org/

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Speake, C., Greenbaum, C.J. Approval of teplizumab: implications for patients. Nat Rev Endocrinol 19, 377–378 (2023). https://doi.org/10.1038/s41574-023-00849-w

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