Provention Bio Inc. (PRVB) says FDA has identified deficiencies for BLA for teplizumab for delay or prevention of clinical type 1 diabetes

Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the Company received a notification on April 2, 2021 from the U.S. Food and Drug Administration (FDA), stating that, as part of its ongoing review of the Company's Biologic License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated in the correspondence that the notification does not reflect a final decision on the information under review.

Additionally, during an informal discussion on April 2, 2021 regarding the agenda for the upcoming Advisory Committee meeting scheduled for May 27, 2021, the FDA informed the Company that it had completed its review of the data and analysis submitted by the Company for its single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study conducted in healthy volunteers. This study evaluated the PK/PD comparability of drug product originating from drug substance manufactured by AGC Biologics, which the Company plans to use for commercialization, and drug product originating from historic drug substance manufactured by Eli Lilly used for the TN-10 study submitted for the teplizumab BLA. The FDA indicated that based on the data it has reviewed to date, the Agency's position is that the PK profiles of the two drug products evaluated in the PK/PD bridging study were not comparable and that additional data would be required before the FDA's considerations could be satisfied. As a follow up, today, the FDA stated to the Company that it is willing to discuss these issues concurrently with its ongoing review.

The FDA intends to continue the review of clinical data submitted in the BLA and to conduct the Advisory Committee meeting, scheduled on May 27, 2021.

"While we believe the FDA's initial feedback will likely result in a delay in timelines within which teplizumab has the potential to be approved by FDA and be made available for at-risk T1D patients, we believe in the comparability of the drug product produced by our partner AGC biologics with Eli Lilly manufactured product. We look forward to working closely with the Agency to address its additional data requirement, so we can deliver teplizumab to patients as soon as possible," said Ashleigh Palmer, CEO and Co-Founder, Provention Bio. "Additionally, we remain enthusiastic about the clinical efficacy and safety data submitted in connection with the BLA in support of teplizumab's potential to address the high unmet needs of at-risk T1D patients and look forward to meeting with the FDA's Advisory Committee and hearing from patients, KOLs and other key stakeholders next month."

Conference Call and Webcast Information:

Provention Bio will discuss these business updates via conference call today at 5:00 pm ET. To access the call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) ten minutes prior to the start time and ask to be connected to the "Provention Bio Call". An audio webcast will also be available on the "Events and Webcasts" page of the Investors section of the Company's website, www.proventionbio.com. An archived webcast will be available on the Company's website approximately two hours after the conference call.

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