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…

Since its approval by the US Food and Drug Administration (FDA) in November, 2022, teplizumab is the first available drug shown to delay the onset of clinical symptoms of type 1 diabetes (stage 3).1 Teplizumab, therefore, offers the possibility of intervening in early stage (stage 2) type 1 diabetes, when the classical clinical signs such as polyuria, polydipsia, and weight loss are absent.2

The US Food and Drug Administration’s (FDA) approval of teplizumab to delay the onset of type 1 diabetes1 could be seen as symbolic, because it came a century after the first use of insulin. Teplizumab, an anti-CD3 monoclonal antibody, is now approved in the USA for people at high risk of type 1 diabetes. This approval is a highly welcome development for this population and all those involved in…