The US FDA has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition. It is administered by intravenous infusion once daily for 14 consecutive days. The specific indication is to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.
Type 1 diabetes staging:
- Stage 1: Presence of beta-cell autoimmunity with two or more islet autoantibodies with normoglycemia
- Stage 2: Beta-cell autoimmunity with dysglycemia yet asymptomatic
- Stage 3: Symptomatic onset of type 1 diabetes.
Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.