Provention Bio Inc. (PRVB) is Resubmitting BLA for Delay of Clinical Type 1 Diabetes in At-Risk Individuals Following Type B Meeting with the FDA

January 27, 2022 4:05 PM EST

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Provention Bio, Inc. (Nasdaq: PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced its intent to resubmit the teplizumab Biologics License Application (BLA) for the delay of clinical type 1 diabetes in at-risk individuals following its Type B pre-BLA resubmission meeting with the U.S. Food and Drug Administration (FDA).

The purpose of the Type B pre-BLA resubmission meeting was to discuss FDA feedback and obtain agreement on Provention's proposed clinical pharmacology data package, including data and analysis from the pharmacokinetic/pharmacodynamic (PK/PD) substudy completed by the Company to address the FDA's PK comparability considerations contained in the complete response letter (CRL) issued last July. In preliminary meeting comments, the FDA noted that the data package presented does not adequately support PK comparability because predicted primary PK parameters are indicative of a lower exposure. To address this concern, 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. On this basis, the FDA agreed that Provention could proceed to resubmit the BLA.

Based on the Company and FDA's agreed upon PK modeling, and the Company's experience with various doses and regimens tested in prior clinical trials, the Company will propose in the BLA resubmission a modified 14-day course of therapy to address the FDA's comparability considerations. The BLA resubmission will also include responses to address the CRL's Chemical, Manufacturing, and Controls (CMC) and product quality considerations, as agreed with the FDA at a Type A meeting held in August last year. The Company believes it will be in a position to resubmit the BLA in the first quarter.

"We are very pleased and excited to be working towards resubmitting the teplizumab BLA, taking the FDA's feedback into account, which gets us another step closer to our goal of delivering teplizumab to individuals and their families who are at risk of developing end-stage, insulin-dependent type 1 diabetes," said Ashleigh Palmer, Co-Founder and CEO of Provention Bio. "We could not be more appreciative of the high level of collaboration and guidance we've experienced throughout this regulatory review process under the FDA's Breakthrough Therapy Designation (BTD). We look forward to re-submitting the BLA as soon as possible and facilitating the FDA's review and decision-making. We continue to prepare the Company for a potential launch of teplizumab with prudently gated spending and planning."

Under applicable FDA guidelines, the FDA has 30 days to review the BLA resubmission, determine whether it is complete and acceptable for review, and provide the due date for action. Under BTD and Priority Review designation, the FDA's guidance is to complete its review within 6 months of the BLA resubmission date.



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