Provention Bio Resubmits BLA For Teplizumab For Delay Of Clinical Type 1 Diabetes - Quick Facts

(RTTNews) - Biopharmaceutical company Provention Bio, Inc. (PRVB) announced Tuesday it 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, as well as the CRL's Chemical, Manufacturing, and Controls (CMC) and product quality considerations.

However, 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 at which the FDA proposed, and 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.

Under applicable FDA guidelines, the FDA has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date.