The U.S. Food and Drug Administration yesterday approved Tzield (teplizumab-mzwv), an injection, to prevent stage 3 type 1 diabetes in adults and children 8 years of age and older who are currently in stage 2.
“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients”, “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”
John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity, FDA.
When the immune system targets and kills the cells that create insulin, type 1 diabetes develops. People who have been diagnosed with type 1 diabetes must monitor their blood sugar levels frequently throughout the day and must administer insulin shots or wear an insulin pump to survive. Although type 1 diabetes can manifest at any age, it is typically detected in children and young people. Although the majority of people with type 1 diabetes do not have a family history, having a parent, brother, or sister with the disease increases a person’s risk.
Tzield attaches to specific immune system cells and prevents type 1 diabetes from progressing to stage 3. Tzield could inhibit the immune cells that target the cells that make insulin while boosting the number of cells that assist control the immunological response. Tzield is infused intravenously once each day for 14 days straight.
A randomised, double-blind, event-driven, placebo-controlled trial including 76 patients with stage 2 type 1 diabetes was conducted to assess the safety and effectiveness of Tzield. Patients in the trial were given an intravenous infusion of Tzield or a placebo once daily for 14 days. The interval between randomization and the onset of a stage 3 type 1 diabetes diagnosis served as the primary indicator of effectiveness. According to the trial findings, stage 3 type 1 diabetes was later diagnosed in 45% of the 44 patients who received Tzield, compared to 72% of the 32 patients who received a placebo over a median follow-up of 51 months.
For patients who got Tzield, the median time from randomization to stage 3 type 1 diabetes diagnosis was 50 months, compared to 25 months for participants who received a placebo. This deceleration of type 1 diabetes stage 3 development is statistically significant.
Tzield’s most frequent adverse reactions are rash, headache, and decreased levels of certain white blood cells. Tzield use is accompanied by warnings and precautions, such as premedicating and monitoring for Cytokine Release Syndrome symptoms; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the requirement to administer all age-appropriate vaccinations before beginning Tzield; and avoiding concurrent use of live, inactivated, and mRNA vaccines with Tzield.