Teplizumab approval for type 1 diabetes in the USA

On Nov 17, 2022, the US Food and Drug Administration (FDA) approved teplizumab as the first disease-modifying therapy in type 1 diabetes. The approval of teplizumab to delay the onset of stage 3 type 1 diabetes in adults and children aged 8 years and older is the culmination of nearly 20 years of investigation and clinical trials of anti-CD3-based therapies. The FDA decision represents a framework-shifting event in the diabetes field and a moment of success for individuals with type 1 diabetes and the research communities, advocacy groups, and funders who have dogmatically pursued the idea that insulin treatment, although lifesaving, is not a cure.