FDA Approves Tzield for Delay of Stage 3 Type 1 Diabetes
The FDA has approved Provention Bio’s Biologics License Application (BLA) for Tzield (teplizumab-mzwv) to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who currently have stage 2 type 1 diabetes.
Type 1 diabetes occurs when the immune system attacks and destroys the cells that make insulin. Stage 3 is the onset of symptomatic disease.
Tzield, an anti-CD3-directed antibody, is indicated for intravenous use as the first immunomodulatory treatment for this patient population. The drug binds to certain immune system cells to delay progression to stage 3.
The agency approval was supported by positive results from a clinical trial in 45 percent of patients taking Tziel were later diagnosed with stage 3 type 1 diabetes compared with 72 percent of the patients who received a placebo.
The drug previously received Priority Review and Breakthrough Therapy designations from the FDA for this indication.