Provention Bio Inc (NASDAQ:PRVB) has resubmitted the Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
- The purpose of the resubmission is to address the FDA’s pharmacokinetic (PK) comparability considerations contained in the complete response letter (CRL) issued last July and the Chemical, Manufacturing & Controls (CMC) and product quality considerations.
- The CRL did not cite any clinical deficiencies related to the efficacy and safety data packages submitted to the original BLA.
- The resubmission comes after last month’s Type B meeting with the FDA. The company agreed to use PK modeling to adjust the 14-day dosing regimen for the planned commercial product to match the exposure of clinical material used in prior clinical trials by ensuring that the 90% confidence intervals for relevant PK parameters fall within the target 80-125% range.
- The therapy narrowly passed the vote at an FDA advisory committee meeting in May last year amid questions about the small study size and more.
- The FDA has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date.
- Price Action: PRVB shares are up 1.85% at $6.60 during the market session on the last check Tuesday.
