FDA approves the first-ever drug that can delay the progression of Type 1 diabetes
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The U.S. Food and Drug Administration (FDA) approved of the first drug that could be used to delay the development and onset of Type 1 diabetes (T1D). The drug is called Teplizumab (Tzield) and is an injectable medication that can push back the onset of this disease. The drug delays 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, mentioned that the drug adds an important new treatment option for patients at-risk of developing diabetes. “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.
What is T1D?
Type 1 diabetes is a disease that is caused by the immune system attacking and destroying cells that create insulin. Insulin is a hormone produced by beta cells within the pancreatic islets, or hormone producing cells. The islets are also called the islets of Langerhans, named after the biologist who discovered them.
People who are diagnosed with Type 1 diabetes 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. If an individual has a parent or sibling with Type 1 diabetes, that person is more likely to also be diagnosed with the disease. However, most patients with T1D do not have a family history.
The approved drug Tzield
Tzield, or Teplizumab, is the first drug to be approved by the FDA that can delay the start of the disease. It was approved through the pharmaceutical company Provention Bio. It works by binding to certain cells within the immune system and delays the progression of Type 1 diabetes.
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 drug is administered intravenously by infusion.
Safety of Tzield
The FDA tested the safety and regulatory properties of the drug. The agency ensured the efficacy, or effectiveness, of Tzield by evaluating the drug in a double-blind, randomized, placebo-controlled trial that consisted of 76 patients with stage 2 Type 1 diabetes. The patients either received Tzield or a placebo by intravenous infusion for 14 days during the trial. In order to measure the efficacy, researchers at the FDA determined the time from randomization (assigning treatment or a placebo to participants) to development of stage 3 Type 1 diabetes.
The results leading to the approval of the drug
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 trial study also showed a time difference in the onset of diabetes. 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. This proved that the drug was effective in delaying the start of diabetes.
Side effects and adverse reactions
The FDA stated on its site that the most common side effects of taking Tzield were headaches, rash and decreased level of lymphocytes, certain types of white blood cells. The agency also warned that there is a risk of serious infections due, in part, to the decreased levels of white blood cells, and risk of hypersensitivity reactions.
The FDA made the announcement about the approval of Tzield on Nov. 17.
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