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# Provention Bio Diabetes Delayer Approved
- URL: https://www.fdaweb.com/provention-bio-diabetes-delayer-approved/
- Published: 2022-11-18T12:00:00.000Z
- Updated: 2026-09-14T18:07:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153229

FDA has approved a Provention Bio BLA for Tzield (teplizumab-mzwv) injection and its use in delaying onset of Stage 3 Type 1 diabetes in adults and pediatric patients eight years of age and older who currently have Stage 2 Type 1 diabetes. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

“Tzield binds to certain immune system cells and delays progression to Stage 3 type 1 diabetes,” FDA says. “Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.”

Side effects of Tzield include decreased levels of certain white blood cells, rash and headache, the agency says. The approval requires warnings and precautions, including premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting therapy; and avoiding concurrent use of live, inactivated and mRNA vaccines.