The U.S. Food and Drug Administration (FDA) has approved the injectable drug Tzield (teplizumab-mzwv) to delay the onset of stage 3 type 1 diabetes, according to a Nov. 17 announcement. This medication manufactured by Provention Bio has the potential to allow individuals at risk for type 1 diabetes to live without the condition for months or even years, according to the agency.

Type 1 diabetes is an autoimmune condition marked by immune cells destroying cells that create insulin. Insulin is a hormone necessary for breaking down glucose into energy for the body. 

Type 1 diabetes occurs in three stages. Stages one and two are mostly symptomless and are only detected with advanced screening. However, once a patient enters stage three of type 1 diabetes, they become reliant on insulin shots or an insulin pump to regulate their blood sugar levels. Type 1 diabetes is most commonly diagnosed in children and young adults, and a family history is not needed to be at risk for type 1 diabetes.

Tzield received Priority Review and Breakthrough Therapy designations for approval. Tzield is an injected drug designed for adults and children over the age of eight who are currently in stage two of type 1 diabetes. Tzield works by binding to immune cells in order to deactivate them, thereby increasing the proportion of immune-moderating cells and delaying the onset of stage three type 1 diabetes. Tzield is injected every day for two weeks.

According to the FDA, in medical trials which were randomized and double-blinded, Tzield was able to delay stage three diagnoses for 50 months compared to 25 months in the placebo group. Additionally, at a 51-month follow-up, 45% of Tzield patients were diagnosed with stage three type 1 diabetes compared to 72% of the control group. The FDA stated that these figures represent “a statistically significant delay in the development of stage 3 type 1 diabetes.”

Tzield presented with some side effects in clinical trials. The most common side effects were decreases in some types of white blood cells, rash, and headache. Tzield may prevent pediatric patients from receiving live, inactivated, or mRNA vaccines, and they may be at risk of hypersensitivity reactions.

Dr. John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, stated, “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.” Dr. Sharretts called Tzield an important new treatment option for at-risk patients.