Provention Bio provides regulatory update on BLA for teplizumab for delay or prevention of type 1 diabetes in at-risk individuals.

Provention Bio, Inc. announced that the Company received a notification from the 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 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.