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USFDA: First Drug Approved by FDA to Delay Type 1 Diabetes Onset

Yesterday (18-November-2022) Tzield (teplizumab-mzwv) injection from ProventionBio has been approved by the U.S. Food and Drug Administration to delay the onset of type 1 diabetes stage 3 in adults and pediatric patients eight years of age and older.

As per the WHO definition "Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces".


Type 1 diabetes (previously known as insulin-dependent, juvenile, or childhood-onset) is characterized by deficient insulin production and requires daily administration of insulin.


Type 2 diabetes (formerly called non-insulin-dependent, or adult-onset) results from the body’s ineffective use of insulin. More than 95% of people with diabetes have type 2 diabetes. This type of diabetes is largely the result of excess body weight and physical inactivity.


The drug binds to specific immune cell types and can delay progress to stage 3 type 1 diabetes, as well as may deactivate immune cells that attack insulin-producing cells while increasing the number of immune cells that regulate the immune response.


A vial of Tzield costs $13,850 (approximately 11.29 lakh INR) and will be administered as an intravenous infusion once daily for 14 consecutive days, resulting in a total of $193,900.


A total of $55 million has been agreed to be paid by Sanofi for marketing rights for Tzield under the Provention Bio/Sanofi partnership.



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