OR WAIT null SECS
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.
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.