The FDA has just approved the first-ever drug to help prevent type 1 diabetes, Teplizumab-mzwv, or Tzield. This is the first drug approved to help delay the onset of type 1 diabetes in those who are almost positive to develop the autoimmune disease. The new treatment is approved for people eight years and older with stage 2 type 1 diabetes. Here's a closer look.
People with type 1 diabetes regularly check their blood sugar levels throughout the day and use insulin to keep everything in check. With this autoimmune disease, the immune system eliminates insulin-producing cells, named beta cells, and the newly founded treatment will act like an antibody made by a body's immune system. Once taken, "the so-called monoclonal antibody latches onto immune cells called T cells and reprograms them, so they don't aggressively attack beta cells in the pancreas," while boosting the number of immune cells needed to counteract these acts, according to ProventionBio, the pharma company.
However, before a person is diagnosed with type 1 diabetes, they go through a few stages beforehand that lead up to developing the full-blown disease. Beta-cell targeting antibodies start to grow in the blood, but sugar remains as usual in stage 1, whereas in stage two, a person's blood sugar levels can begin to rise more intensely without showing any symptoms. It is in stage 3 where beta cells have been broken down, and symptoms start to occur, such as high blood sugar levels, weight loss, frequent urination, or diabetic ketoacidosis.
Breaking news: The FDA has just approved Tzield (teplizumab) as the first-ever disease-modifying therapy to delay the onset of type 1 diabetes. To learn more about screening for T1D & Tzield as a potential therapeutic option to delay the onset of T1D visit https://t.co/vsfN8xwOOM pic.twitter.com/RbAlmFj7zW— TCOYD (@TCOYD) November 17, 2022
The trial included 76 participants between the ages of 8 and 49 with stage 2 type 1 diabetes; half received the new treatment, and the other half received a placebo. Some members found headaches, rashes, or decreased numbers of immune cells due to the new drug. However, patients' immune cells began to bounce back within a short period of time. The clinical trial for teplizumab-mzwv has the "potential to delay clinical diagnosis of type 1 diabetes" and "provide patients with months to years without the burdens of disease," according to Dr. John Sharrets, the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug and Evaluation and Research. Tzield is being sold for $13,850 a vial, according to USA Today. Stay tuned while this story develops.