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# FDA Identifies Deficiencies in Provention BLA
- URL: https://www.fdaweb.com/fda-identifies-deficiencies-in-provention-bla/
- Published: 2021-04-09T12:00:00.000Z
- Updated: 2026-09-14T16:54:18.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149081

FDA has told Provention Bio that it has identified deficiencies with its BLA for diabetes therapy teplizumab that preclude labeling and post-marketing requirements/commitments discussions at this time. The agency’s notification stated the deficiencies do not reflect a final decision on the information under review, the company says. Additionally, the review concerns are not precuding the agency from continuing with a planned 5/27 Endocrinologic and Metabolic Drugs Advisory Committee meeting, according to Provention.  

FDA also informed the company that it had completed its review of data and an analysis submitted for its single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study. “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 company says. “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.”