FDA Extends Review of Diabetes Therapy Teplizumab


The new PDUFA date is Nov. 17, 2022. If approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes.

The FDA has extended its review of the biologics license application (BLA) for Provention Bio’s teplizumab for the delay of type 1 diabetes in at-risk patients. The extended user fee goal date is now Nov. 17, 2022; the original date was Aug. 17. 2022.

Teplizumab is humanized anti-CD3 monoclonal, and if approved, it will be the first disease-modifying therapy for type 1 diabetes.

In February, the company had resubmitted it application after receiving a complete response letter from the FDA in November 2021, indicating that regulators wanted to see a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers. Regulators wanted to see data that compared the 14-day dosing regimen for the planned commercial product with the exposure of clinical material used in prior clinical trials.

Related: Provention Bio Resubmits Application for Teplizumab

If no major deficiencies are identified during the review period, the FDA plans to communicate proposed labeling and, if necessary, any post-marketing requirement or commitment requests by Oct. 17, 2022, according to a company press release.

The company is also evaluating teplizumab in patients with newly diagnosed insulin-dependent type 1 diabetes in the phase 3 PROTECT study. The study reached it enrollment target during the third quarter of 2021, and Provention Bio expects to report top-line data from the study in the second half of 2023.

Recent Videos
Video 5 - "Obstacles in Adapting Diabetes Technology to Individual Needs" - 1 KOL is featured
Video 4 - "The Impact of Continuous Glucose Monitors & Digital Solutions on Diabetes Care"
Video 3 - "The Pivotal Role of Patient Engagement and Education in Achieving Optimal Diabetes Outcomes"
Video 2 - "Addressing Coexisting Conditions: Keys to Comprehensive Diabetes Care"
Video 1 - "The Influence of Social Determinants of Health on Diabetes Care and Outcomes"
Video 6 - "Failing to Reach Ideal Diabetes Care: Equitable Doesn’t Mean Equal"
Video 5 - "Revising Diabetes Outcome Measures"
Video 10 - "Managing Self Care"
Video 3 - "Embracing and Improving Access to Technology Tools"
Video 8 - "Demographic Differences That Impact Care"
Related Content
© 2024 MJH Life Sciences

All rights reserved.