After clinical trials, the U.S. Food and Drug Administration approves the first drug that can delay the progression of Type-1 Diabetes.

On Nov. 17, the FDA released its statement regarding the approval of Tzield. The drug Tzield, or Teplizumab, is the first medication that can prevent the onset of Type-1 Diabetes produced by New Jersey-based biopharma company Provention Bio. The drug attaches to specific immune system cells and slows the evolution of Type 1 diabetes, according to the U.S. FDA's official statement.

Additionally, the FDA has found that Tzield could be able to stop immune cells from attacking cells that make insulin. Its effect also boosts the percentage of cells that control how the immune system reacts. An intravenous infusion is used to give the medication.

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FDA's Clinical Trials on Tzield Drug

According to Interesting Engineering, the FDA examined the new drug's safety and regulatory capabilities. The organization verified Tzield's efficacy by testing the medication on 76 individuals with stage 2 Type 1 diabetes in a double-blind, randomized, placebo-controlled experiment.

Throughout the 14-day experiment, the patients took Tzield or a placebo drug. Researchers at the FDA calculated the amount of time that had passed since participants were randomly assigned to receive the medication or a placebo before developing stage 3 Type 1 diabetes to gauge the effectiveness.

Additionally, the FDA's Center for Drug Evaluation and Research Director of the Diabetes division Dr. John Sharretts, attested that the drug adds an important new treatment option for patients at risk of developing diabetes in their public statement.

"Today's approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients," Dr. Sharretts explained. "The drug's potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease."

FDA Warns Public of Tzield Side Effects, Effectivity

The FDA also detailed their trial study in their recent statement, revealing that patients who got Tzield experienced stage 3 T1D 50 months after randomization, but those who received the placebo had it 25 months sooner. This demonstrated that the medication was successful in postponing the onset of diabetes.

The FDA reported on its website that headaches, rashes, and a reduction in lymphocytes, which is a particular type of white blood cell, were the most frequent negative effects of taking Tzield. 

The agency also cautioned that there is a danger of hypersensitivity reactions and a risk of serious infections because of the decreased levels of white blood cells.

Amber Specialty Pharmacy to Dispense TZIELD

Additionally, Yahoo reports that Amber Specialty Pharmacy will be dispensing the Tzielddrug, specifically to people with Stage 2 T1D who are eight years of age or older. 

With 19 sites and ambulatory and home infusion capabilities, the specialty pharmacy is prepared to provide care for certain types of Diabetic patients. Amber Specialty Pharmacy's high touch, infusion-focused service model, is created to help provider offices and eligible Stage 2 T1D patients across the nation who may be given teplizumab prescriptions.

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Written by: Andi C.