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Today, the U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes 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, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation. and research. “The drug’s potential to delay the clinical diagnosis of type 1 diabetes could leave patients without disease burden for months to years.”

Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that make insulin. People with a type 1 diabetes diagnosis have elevated glucose levels that require insulin injections (or wearing an insulin pump) to survive, and they need to monitor their blood sugar levels regularly throughout the day. Although it can occur at any age, type 1 diabetes is most commonly diagnosed in children and young adults. A person is at greater risk for type 1 diabetes if they have a parent, brother, or sister with type 1 diabetes, although most patients with type 1 diabetes have no family history.

Tzield binds to certain cells of the immune system and slows progression to stage 3 type 1 diabetes. Tzield can deactivate the immune cells that attack insulin-producing cells while increasing the number of cells that help moderate the immune response. Tzield is given as an intravenous infusion once a day for 14 consecutive days.

The safety and efficacy of Tzield were evaluated in a randomized, double-blind, event-driven, placebo-controlled study of 76 patients with stage 2 type 1 diabetes. In the study, patients were randomized to receive Tzield or placebo by intravenous infusion once daily for 14 days. . The primary measure of effectiveness was the time from randomisation to the development of a diagnosis of type 1 stage 3 diabetes. The results of the study showed that over a median follow-up of 51 months, in 45% of the 44 patients who received Tzield , later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo. The mean 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 placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes.

The most common side effects of Tzield are decreased levels of certain white blood cells, rash, and headache. The use of Tzield is associated 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 cell called lymphocytes; risk of hypersensitivity reactions; the need to have all age-appropriate vaccinations before starting Tzield; as well as avoiding the concomitant use of live, inactivated, and mRNA vaccines with Tzield.

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

The FDA approved Tzield for Provention Bio.

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The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.