Tzield (teplizumab-mzwv) injection was approved by the US Food and Drug Administration two weeks ago to delay the onset of stage 3 type 1-diabetes in adults and paediatric patients 8 years and older who are currently in stage 2-type diabetes.
“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”
Type 1 diabetes is a condition in which the immune system attacks and destroys insulin-producing cells. People with type 1 diabetes have high glucose levels that necessitate insulin shots (or the use of an insulin pump) to survive, and they must monitor their blood sugar levels throughout the day.
Tzield binds to specific immune system cells, delaying progression to type 1 diabetes stage 3. Tzield may deactivate immune cells that attack insulin-producing cells while increasing the proportion of immune-moderation cells. Tzield is administered intravenously once daily for 14 days in a row.
Tzield’s safety and efficacy were studied in 76 patients with stage 2 type 1 diabetes in a randomized, double-blind, event-driven, placebo-controlled trial. Patients in the trial were randomly assigned to receive Tzield or a placebo once daily via intravenous infusion for 14 days.
The time from randomization to the development of stage 3 type 1 diabetes was used as the primary efficacy measure.
The median time from randomization to stage 3 type 1 diabetes diagnosis for patients who received Tzield was 50 months and 25 months for those who received a placebo. This represents a statistically significant delay in the onset of type 1 diabetes at stage 3. Tzield’s most common side effects are decreased levels of certain white blood cells, rash, and headache.
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