Abstract:
The US Food and Drug Administration's (FDA) approval of teplizumab to delay the onset of type 1 diabetes 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 the care and wellbeing of people with type 1 diabetes. However, in our opinion, the approval of teplizumab should be interpreted with caution. A global health perspective must consider evidence, cost, patient preferences, and equity...