The U.S. Food and Drug Administration approved Tzield injection (teplizumab-mzwv) to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have type 1 diabetes in stage 2.
"Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients," said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders and Obesity at the Evaluation Center. of FDA Drugs and Research. “The drug’s potential to delay the clinical diagnosis of type 1 diabetes may provide patients with months or years free from the burden of the disease.”
Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that produce insulin. People diagnosed with type 1 diabetes have increased glucose that requires insulin injections (or the use of an insulin pump) to survive and must monitor their blood sugar levels regularly throughout the day. Although it can appear at any age, type 1 diabetes is usually diagnosed in children and young adults. A person is at increased risk for type 1 diabetes if they have a parent, brother, or sister with type 1 diabetes, although most patients with type 1 diabetes have no family history.
Tzield binds to certain immune system cells and slows progression to stage 3 type 1 diabetes.
Tzield can deactivate immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response. Tzield is administered by intravenous infusion once a day for 14 consecutive days.
The safety and effectiveness of Tzield were evaluated in a randomized, double-blind, event-based, placebo-controlled trial with 76 patients with stage 2 type 1 diabetes. In the trial, patients randomly received Tzield or a placebo once a day. day by intravenous infusion for 14 days. The primary measure of efficacy was the time from randomization to developing a diagnosis of stage 3 type 1 diabetes.
The trial results showed that during a median follow-up of 51 months , 45% of the 44 patients who received Tzield were subsequently diagnosed with stage 3 type 1 diabetes, compared with 72% of the 32 patients who received a placebo . The median time from randomization to diagnosis of stage 3 type 1 diabetes was 50 months for patients receiving Tzield and 25 months for those receiving placebo.
The most common side effects of Tzield include reduced levels of certain white blood cells, rash, and headache. Use of Tzield comes with warnings and precautions, including premedication and monitoring for cytokine release syndrome symptoms; risk of serious infections; decreased levels of a type of white blood cells called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccines before starting Tzield; as well as avoid the simultaneous use of live, inactivated and mRNA vaccines with Tzield.
