The U.S. Food and Drug Administration said it has approved Provention Bio Inc.’s Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.
In pre-market activity on Nasdaq, Provention Bio shares were gaining around 9.7 percent to trade at $9.04.
Tzield is the first drug approved by FDA that can delay onset of type 1 diabetes, which occurs when the immune system attacks and destroys the cells that make insulin.
People with a type 1 diabetes diagnosis requires insulin shots or wearing an insulin pump to survive and must check their blood sugar levels regularly throughout the day.
Tzield injection binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. The FDA noted that Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.
Tzield is administered by intravenous infusion once daily for 14 consecutive days.
The approval was given after 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 percent of the 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared to 72 percent of the 32 patients who received a placebo.
The trial results showed a statistically significant delay in the development of stage 3 type 1 diabetes.
Tzield received Priority Review and Breakthrough Therapy designations for this indication.
John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said, “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”
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