Provention Bio, Inc. (NASDAQ: PRVB) disclosed that FDA gave the green signal regarding the resubmission of Teplizumab. On January 27, 2022, the company revealed that it has decided to resubmit the teplizumab Biologics License Application (BLA) for the postponement of clinical type 1 diabetes in at-risk individuals after its Type B pre-BLA resubmission meeting with the U.S. FDA.
Finally, Provention has confirmed that had settled the comparability matters with the FDA and now Teplizumab got the green signal from FDA for resubmission. The news has helped the company stock to surge to 21.18% at the time of writing on Friday. Provention Bio has a total trading volume of 7.63 million at the time of writing on Friday.
Furthermore, the company disclosed that the resubmission will also incorporate answers to the FDA's questions about chemical, production, and controls, along with product quality considerations. The type A meeting was scheduled in August last year. Earlier, the therapy narrowly got the vote at an FDA advisory committee meeting in May last year during questions about the small study size and more.
In addition, the FDA strike back teplizumab with a complete response letter and snub the application. Moreover, the agency interrogated data related to the drug substance to be used in the commercial product and requested a safety update in a resubmission. The resubmission should be scheduled for Q1 of FY22.
Provention has also confirmed that it has decided to use pharmacokinetic modeling to change the 14-day dosing regimen for the commercial product to match the exposure seen with the material used in the treatment's clinical trials after discussions with the FDA. The company will suggest a modified 14-day course to tackle the FDA's issues.