FDA approves first drug to prevent Type 1 diabetes

On Nov. 17, the U.S. Food and Drug Administration (FDA) approved the first drug to delay the onset of Type 1 diabetes. Tzield (teplizumab-mzwv), manufactured by Provention Bio, “adds an important new treatment option for certain at-risk patients,” John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a statement. “The drug’s potential to delay clinical diagnosis of Type 1 diabetes may provide patients with months to years without the burdens of disease.”

Tzield received priority review from the FDA, a status given to drugs with the potential for “significant improvement” in the treatment, diagnosis, or prevention of a serious condition. The drug is also considered a Breakthrough Therapy, a designation meant to expedite the development and review of drugs that can “demonstrate substantial improvement over available therapy.”

How Tzield works

Type 1 diabetes is one of three main types of diabetes: Type 1, Type 2, and gestational diabetes, which only affects pregnant people. Type 2 is the most common type of diabetes. According to the Centers for Disease Control and Prevention (CDC) and JDRF, there are more than 37 million people with diabetes (about 90 to 95% of which have Type 2 diabetes) and about 1.45 million people living with Type 1 diabetes in the United States.  

Type 1 diabetes develops when the body no longer produces enough of the hormone known as insulin—or any insulin—to help move sugar from the bloodstream into the body’s cells to use for energy. People with Type 1 diabetes must take insulin to replace what their body can’t produce. It’s considered an autoimmune disease because the immune system attacks the beta cells in the pancreas that produce insulin.