The FDA has approved Tzield® (teplizumab-mzwv) for use in adult patients with stage 3 type 1 diabetes and in paediatric patients eight years and older with stage 2 type 1 diabetes. 

The injectable is the first-in-class treatment which delays the onset of diabetes in these at-risk patients by binding to specific immune cells, potentially deactivating those attacking insulin-producing cells. This is thought to delay the progression to stage 3 type 1 diabetes by shifting the immune response toward a more moderated state, increasing the proportion of cells that help regulate the immune response.

In a randomized, double-blind, placebo-controlled trial involving 76 patients with stage 2 type 1 diabetes, Tzield® was administered via intravenous infusion for 14 days. The primary measure of efficacy, the time to development of stage 3 type 1 diabetes, showed that 45% of the patients who received Tzield® were diagnosed over a median follow-up of 51 months, compared to 72% of those who received a placebo. The mid-range time to diagnosis was 50 months with Tzield and 25 months with the placebo, indicating a statistically significant delay in progressing to stage 3 type 1 diabetes with Tzield® treatment.

The injectable received Priority Review and Breakthrough Therapy designations for this indication.

Quoted in the FDA Press release¹, John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, commented:  “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.”¹