First-ever drug that can delay the progression of Type 1 diabetes approved by FDA

On November 17, the U.S. Food and Drug Administration (FDA) approved the first-ever drug that could be used to delay the development and onset of Type 1 diabetes.

The drug known as Teplizumab (Tzield), is an injectable medication that can delay the onset of this illness. Tzield delays the onset of Type 1 diabetes in adults at stage three and in children (8 years of age and older) at stage two.

According to Dr. John Sharretts, the director of Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, the medication offers patients who are at-risk of developing diabetes a significant new therapeutic option.

“Today’s approval of a first-in-class therapy offers a crucial new treatment option for certain at-risk patients. The drug’s potential to postpone the clinical diagnosis of type 1 diabetes may give patients months or years without the burdens of the illness,” he said.

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Tzield and How It Works

Tzield is the first drug to be approved by the FDA that can delay the development of Type 1 diabetes. The approval came through the pharmaceutical company Provention Bio. The drug works by binding to certain cells within the immune system and delays the progression of Type 1 diabetes.

Tzield could be able to stop immune cells from attacking cells that make insulin. Additionally, it would boost the percentage of cells that control how the immune system reacts. The drug is administered intravenously by infusion.

The FDA examined the drug’s safety and regulatory properties. The organization verified Tzield’s efficacy by testing the medication on 76 patients with stage 2 Type 1 diabetes in a double-blind, randomized, and placebo-controlled experiment. Throughout the 14-day trial, the patients either received Tzield or a placebo by intravenous infusion.

In order to measure the efficacy, researchers at the FDA determined the time from randomization (assigning treatment or a placebo to participants) to the development of stage 3 Type 1 diabetes. The researchers checked the patients’ progression with a follow-up of 51 months.

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The Outcome of the Experiment

The results showed that 45% of the 44 patients who received Tzield were later diagnosed with stage 3 Type 1 diabetes, while 72% of the 32 patients who received the placebo tested for the same disorder.

The results also showed a time difference in the onset of diabetes. The time from randomization to stage 3 Type 1 diabetes for those who received Tzield was 50 months, and patients who received the placebo had an earlier onset at 25 months. This proved that the drug was effective in delaying the start of diabetes.

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