The U.S. Food and Drug Administration (FDA) has approved the first drug that could be used to delay the development and onset of Type 1 diabetes (T1D). The drug is named Teplizumab (Tzield). It comes as an injectable medication and it can delay the onset of Type 1 diabetes in adults at stage three and in children aged eight years and older at stage two.
Dr. John Sharretts, the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research states, “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease,” he said.
People with this condition have increased glucose and must either take insulin shots or wear an insulin pump to regulate their insulin levels. T1D is usually diagnosed in children and young adults. It can also be transferred from one generation to another.
Tzield could potentially deactivate the immune cells that attack insulin-producing cells. It also would increase the proportion of cells that moderate the immune system’s response.
The FDA evaluated the drug in a double-blind, randomized, placebo-controlled trial that consisted of 76 patients with stage 2 Type 1 diabetes.
The researchers checked the participants’ progression with a follow-up of 51 months. The results showed that 45% of the 44 patients who received Tzield were later diagnosed with stage 3 Type 1 diabetes, while 72% of the 32 patients who received the placebo tested for the same disorder.
The time from randomization to stage 3 T1D for those who received Tzield was 50 months, and patients who received the placebo had an earlier onset at 25 months.
The side effects of Tzield were headaches, rash, and decreased levels of lymphocytes, certain types of white blood cells. There also might be a risk of infections.
The FDA made the announcement about the approval of Tzield on Nov. 17.