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# Provention Bio Refiles BLA for Diabetes Therapy
- URL: https://www.fdaweb.com/provention-bio-refiles-bla-for-diabetes-therapy/
- Published: 2022-03-22T12:00:00.000Z
- Updated: 2026-09-14T17:37:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151424

Provention Bio has resubmitted its BLA for teplizumab for the delay of clinical Type 1 diabetes (T1D) in at-risk individuals. The agency has set an 8/17 user fee review action target date.

In 7/2021, FDA issued a complete response letter stating that a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers to compare the planned commercial product with the drug product originating from the drug substance manufactured for clinical trials had failed to show PK comparability, according to the company. “As PK remains the primary endpoint for demonstration of comparability between the two products, you will need to establish PK comparability appropriately between the intended commercial product and the clinical trial product or provide other data that adequately justify why PK comparability is not necessary,” the company quoted the agency as saying.

At the time, Provention said relevant additional PK/PD data being collected from a PK/PD substudy in patients receiving 12 days of therapy in the ongoing Phase 3 PROTECT trial in newly diagnosed T1D patients would be available by 9/30/2021\. It also said the data will be analyzed by independent, unblinded third parties to maintain the integrity of the placebo-controlled trial.

Additionally, the company said the agency letter cited deficiencies discussed during a recent general inspection, not specific to teplizumab, at a fill/finish manufacturing facility used by the company that will need to be resolved before approval could be granted.