FRIDAY, Nov. 18, 2022 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved the first drug that could delay the development of stage 3 type 1 diabetes in adults and children 8 years and older who currently have stage 2 type 1 diabetes.
Tzield (teplizumab) targets the autoimmune issues that drive the disease, rather than its symptoms, making the medication a game changer. According to an FDA news release, it is thought that Tzield "may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response."
"Today's approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients," John Sharretts, M.D., director of the division of diabetes, lipid disorders, and obesity in the FDA Center for Drug Evaluation and Research, said in the news release. "The drug's potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease."
The safety and efficacy of Tzield were evaluated in a randomized, double-blind, event-driven, placebo-controlled trial. Seventy-six patients with stage 2 type 1 diabetes were randomly assigned to either Tzield (44 patients) or a placebo (32 patients) once daily via intravenous infusion for 14 days. Participants were followed for a median of 51 months.
According to the results of the trial, 45 percent of patients who received Tzield were later diagnosed with stage 3 type 1 diabetes compared with 72 percent of patients who received placebo. The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 and 25 months for patients receiving Tzield and placebo, respectively. The trial results indicated a statistically significant delay in the development of stage 3 type 1 diabetes.
Advocates applauded the approval. "A delay in the onset of type 1 diabetes will have a tremendous impact on the daily lives of people at risk for diabetes, their families, and the overall health system," Aaron Kowalski, CEO of the nonprofit JDRF (formerly the Juvenile Diabetes Research Foundation), said in a statement. "It would free them from the constant burden and stress of blood-sugar monitoring and insulin administration. It would free them from the worry and fear of short- and long-term complications, while giving them the opportunity to learn more about disease management."
Approval of Tzield was granted to Provention Bio.