Drug approved to delay onset of stage 3 type 1 diabetes
The first-in-class therapy, indicated in adults and pediatric patients ages 8 years and older who currently have stage 2 type 1 diabetes, is administered by IV infusion once daily for 14 consecutive days.
The FDA announced on Nov. 17 that it has approved a treatment to delay the onset of stage 3 type 1 diabetes.
Teplizumab-mzwv (Tzield) injection is indicated to delay the onset of stage 3 (or symptomatic) type 1 diabetes in adults and pediatric patients ages 8 years and older who currently have stage 2 type 1 diabetes (defined as beta-cell autoimmunity with dysglycemia but no symptoms). The first-in-class therapy is administered by IV infusion once daily for 14 consecutive days.
In a trial of 76 patients with stage 2 type 1 diabetes, more patients who received placebo were later diagnosed with stage 3 type 1 diabetes compared to those who received the drug. The most common side effects include decreased levels of certain white blood cells, rash, and headache. The drug also carries warnings and precautions, including premedicating and monitoring for symptoms of cytokine release syndrome, risk of serious infections, decreased lymphocyte levels, risk of hypersensitivity reactions, and the need to administer all age-appropriate vaccinations before initiation, as well as avoiding concurrent use of live, inactivated, and mRNA vaccines.