The FDA approved Tzield® (teplizumab-mzwv) injections, a new drug that can delay the onset of stage 3 type 1 diabetes by several months or years.
Type 1 diabetes occurs when the immune system attacks and destroys the cells that make insulin, requiring individuals to check their blood sugar regularly and deliver insulin shots to survive. Tzield deactivates the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune system.
Tzield’s safety and efficacy were evaluated in a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients with stage 2 type 1 diabetes. In the trial, patients randomly received Tzield or a placebo once daily via intravenous infusion for 14 days. The primary measure of efficacy was the time from randomization to development of stage 3 type 1 diabetes diagnosis.
The trial results showed that over a median follow-up of 51 months, 45% of the 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo. The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes.
Tzield must be delivered intravenously once daily for 14 consecutive days. The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache.
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