For immediate release:

Today, the United States Food and Drug Administration approved Tzield (teplizumab-mzwv) injection for delaying the onset of type 1 diabetes mellitus stage 3 in adults and pediatric patients 8 years of age and older who currently have stage 2 type 1 diabetes.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, MD, Division Director of Diabetes, Lipid Disorders and obesity at the FDA’s Center for Drug Evaluation. and Research. “The drug’s potential to delay the clinical diagnosis of type 1 diabetes can provide patients with months or even years without the burden of the disease.”

Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that make insulin. People with type 1 diabetes have high blood sugar levels that require insulin injections (or wearing an insulin pump) to survive and need to check their blood sugar regularly throughout the day. Although it can appear at any age, type 1 diabetes is usually diagnosed in children and young adults. A person is at higher risk for type 1 diabetes if they have a parent or sibling with type 1 diabetes, although most patients with type 1 diabetes do not have a family history .

Tzield binds to certain immune system cells and delays progression to type 1 stage 3 diabetes. Tzield can deactivate 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 safety and efficacy of Tzield was evaluated in a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients with type 1 stage 2 diabetes. In the trial, patients randomly received Tzield or placebo once daily by intravenous infusion for 14 days. The primary efficacy endpoint was the time from randomisation to development of the diagnosis of stage 3 type 1 diabetes. The trial results showed that over a median follow-up of 51 months, 45% of 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared with 72% of the 32 patients who received placebo. The average time from randomisation to diagnosis of stage 3 type 1 diabetes was 50 months for patients who received Tzield and 25 months for those who received placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes.

The most common side effects of Tzield include decreased levels of certain white blood cells, skin rashes, and headaches. Use of Tzield comes with warnings and precautions, including premedication and monitoring for symptoms of cytokine release syndrome; risk of serious infections; decreased levels of a type of white blood cells called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccines before starting Tzield; as well as avoiding the simultaneous use of live, inactivated and mRNA vaccines with Tzield.

Tzield has received Priority Review and Breakthrough Therapy designations for this indication.

The FDA granted Tzield approval to Provention Bio.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.