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.