The U.S. Food and Drug Administration has approved a new drug called Tzield (teplizumab) to delay the onset of stage 3 type 1 diabetes. This medicine is for adults and children aged 1 year and older who have stage 2 type 1 diabetes. Stage 2 means they have certain antibodies and abnormal blood sugar levels but do not yet need insulin. Tzield is a CD3-directed antibody that works by targeting the immune system to slow the attack on insulin-producing cells. This approval offers a new option for people at high risk of developing insulin-dependent diabetes. Before starting treatment, doctors should confirm the diagnosis of stage 2 type 1 diabetes using an oral glucose tolerance test or another reliable method and ensure the condition is autoimmune in origin. While this is a significant step forward, it is important to understand that Tzield does not cure or prevent type 1 diabetes. It only delays the progression to stage 3, when insulin therapy becomes necessary. If you or a loved one has stage 2 type 1 diabetes, talk to your doctor about whether Tzield might be an appropriate option for you.
FDA approved Tzield (teplizumab) to Delay Onset of Stage 3 Type 1 DiabetesFDA approved Tzield to delay type 1 diabetes in high-risk patients
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The FDA has approved Tzield (teplizumab), a CD3-directed antibody, to delay the onset of Stage 3 type 1 diabetes in adult and pediatric patients 1 year of age and older with Stage 2 type 1 diabetes. Stage 2 T1D is defined by the presence of at least two positive pancreatic islet autoantibodies and dysglycemia without overt hyperglycemia. This approval provides a new therapeutic option for patients at high risk of progressing to insulin-dependent diabetes. Clinicians should confirm the diagnosis of Stage 2 T1D using an oral glucose tolerance test or alternative method and ensure autoimmune origin before initiating treatment.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Tzield is a CD3-directed antibody. The exact mechanism by which it delays the onset of Stage 3 type 1 diabetes is not fully elucidated in the label.
Tzield is indicated to delay the onset of Stage 3 type 1 diabetes in adult and pediatric patients 1 year of age and older with Stage 2 type 1 diabetes. Stage 2 T1D is defined by at least two positive pancreatic islet autoantibodies and dysglycemia without overt hyperglycemia, as confirmed by oral glucose tolerance test or alternative method.
Tzield is administered as an intravenous infusion once daily for 14 consecutive days. Dosing is based on body surface area: Day 1: 65 mcg/m², Day 2: 125 mcg/m², Day 3: 250 mcg/m², Day 4: 500 mcg/m², Days 5-14: 1,030 mcg/m². Infusion duration is a minimum of 30 minutes for patients aged 8 years and older, and 2 hours for patients aged 1 to less than 8 years. Premedication with an NSAID or acetaminophen, an antihistamine, and consideration of an antiemetic is recommended before each of the first 5 doses. Prior to initiation, obtain a complete blood count, liver enzymes, and evaluate for active EBV and CMV infection with undetectable viral load. Administer age-appropriate vaccines: live vaccines at least 8 weeks before, inactivated or mRNA vaccines at least 2 weeks before.
Trial data not available in label.
Tzield is not recommended in patients with lymphocyte count <1,000/mcL, hemoglobin <10 g/dL, platelet count <150,000/mcL, absolute neutrophil count <1,500/mcL, ALT or AST >2x ULN, bilirubin >1.5x ULN, active serious infection or chronic active infection other than localized skin infections, or laboratory or clinical evidence of active EBV or CMV infection. Monitor lymphocyte count every 2-3 days during treatment; permanently discontinue if prolonged severe lymphopenia (<500 cells/mcL lasting ≥1 week) develops. Monitor for viral reactivation during and for at least 2 months after treatment; discontinue if suspected. Monitor liver enzymes and bilirubin.
Tzield is the first therapy approved to delay the onset of Stage 3 type 1 diabetes in patients with Stage 2 disease. It should be used in patients who meet the diagnostic criteria for Stage 2 T1D and after excluding other forms of diabetes.
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