Published on 30 November 2022

US FDA approved Teplizumab could help people at risk of developing type 1 diabetes.


An injection treatment that could delay the onset of type 1 diabetes has been approved in the US – a development which some have described as one of the biggest breakthroughs in treating the condition since the discovery of insulin 100 years ago.


Teplizumab was recently approved by the Food and Drug Administration (FDA) in the US to delay the onset of type 1 diabetes in adults and children aged 8 and over.


John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said: “The approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients. The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of the condition.” 


Type 1 diabetes can develop when the immune system attacks and destroys the cells that make insulin. People with a type 1 diabetes diagnosis have increased glucose that requires insulin injections (or using a wearable insulin pump) to survive and must check their blood sugar levels regularly throughout the day. Although it can appear at any age, type 1 diabetes is usually diagnosed in children and young adults. A person is at higher risk for type 1 diabetes if they have a parent, brother or sister with type 1 diabetes, although most patients with type 1 diabetes do not have a family history.

Mother And Child Checking Blood Sugar

The teplizumab injection binds to certain immune system cells and delays progression to type 1 diabetes. Teplizumab may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response. Teplizumab is administered by injection once daily for 14 consecutive days. 

In tests teplizumab’s safety and efficacy were evaluated in a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients in the developing stages of type 1 diabetes.

Teplizumab is under review in the UK, but it has not yet been approved. However, the approval in the US could begin the process for this life-changing treatment to be made available to people at high risk of type 1 diabetes in the UK at a later date.

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