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.
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