Tzield FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 23, 2022.
FDA Approved: Yes (First approved November 17, 2022)
Brand name: Tzield
Generic name: teplizumab-mzwv
Dosage form: Injection
Company: Provention Bio, Inc.
Treatment for: Delaying the Onset of Stage 3 Type 1 Diabetes
Tzield (teplizumab-mzwv) is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
- Type 1 diabetes is an autoimmune disease that occurs when the immune system attacks and destroys the beta cells in the pancreas that make insulin.
- Tzield works to delay the onset of stage 3 type 1 diabetes by binding to CD3 (a cell surface antigen present on T lymphocytes) to deactivate the immune cells that attack insulin-producing cells.
- Tzield is administered via intravenous infusion (over a minimum of 30 minutes) once daily for 14 days. Patients must meet the criteria for a diagnosis of Stage 2 type 1 diabetes.
- Warnings and precautions associated with Tzield include cytokine release syndrome (CRS), serious infections, lymphopenia, and hypersensitivity reactions.
- Common adverse reactions include lymphopenia, rash, leukopenia and headache.
Development timeline for Tzield
| Date | Article |
|---|
| Nov 17, 2022 | Approval FDA Approves Tzield (teplizumab-mzwv) to Delay the Onset of Stage 3 Type 1 Diabetes |
| Oct 6, 2022 | Provention Bio to Combine Forces with Sanofi to Support Potential U.S. Launch of Teplizumab for Delay in Onset of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals |
| Jun 30, 2022 | Provention Bio Announces Extension of FDA User Fee Goal Date for Teplizumab to November 17, 2022 |
| Mar 21, 2022 | Provention Bio Announces FDA Acceptance of the Biologics License Application (BLA) Resubmission for Teplizumab for the Delay of Clinical Type 1 Diabetes in At-Risk Individuals |
| Feb 22, 2022 | Provention Bio Announces Biologics License Application (BLA) Resubmission for Teplizumab to Address Complete Response Letter (CRL) |
| Jul 6, 2021 | Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals |
| Mar 3, 2021 | Provention Bio Announces Publication of Extended Follow-up Data from the Pivotal "At-Risk" TN-10 Study of Teplizumab in Science Translational Medicine |
| Jan 4, 2021 | Provention Bio Announces U.S. FDA Filing of a Biologics License Application (BLA) and Priority Review for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals |
| Nov 2, 2020 | Provention Bio Completes Rolling Submission of the Biologics License Application (BLA) for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals |
| Jun 15, 2020 | Provention Bio's Teplizumab Continued to Significantly Delay the Onset of Insulin-Dependent Type 1 Diabetes (T1D) in Presymptomatic Patients |
| Apr 9, 2019 | Provention Bio Initiates Phase 3 PROTECT Clinical Trial with PRV-031 (Teplizumab) in Patients with Recent Onset Type 1 Diabetes |
Further information
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