FDA Approves First Treatment to Delay Stage 3 Type 1 Diabetes
The FDA has approved the first treatment to delay the onset stage of type 1 diabetes. Teplizumab-mzwv (Tzield), an injection, was approved for use in adults and pediatric patients aged 8 years and older who currently have stage 2 type 1 diabetes.
“The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease,” said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a press release.
The approval of teplizumab-mzwv follows a randomized, double-blind, event-driven, placebo-controlled trial, in which 76 patients with stage 2 type 1 diabetes randomly received teplizumab-mzwv or a placebo once daily for 14 days by intravenous infusion. Of the total, 44 patients received treatment, and 32 patients received a placebo.
At a median follow up of 51 months, 45% of patients who received teplizumab-mzwv were later diagnosed with stage 3 type 1 diabetes, compared to 72% who did not receive treatment. The results showed a statistically significant delay of stage 3 type 1 diabetes.
Common adverse events include decreased levels of certain white blood cells, rash, and headache. Additionally, the use of teplizumab-mzwv comes with warnings and precautions such as premedicating and monitoring for symptoms of Cytokine Release Syndrome, and the risks of serious infections.
FDA approves first drug that can delay onset of type 1 diabetes. News release. US Food and Drug Administration; November 17, 2022. Accessed November 18, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes?utm_medium=email&utm_source=govdelivery