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# FDA Complete Response on Provention’s Teplizumab
- URL: https://www.fdaweb.com/fda-complete-response-on-proventions-teplizumab/
- Published: 2021-07-06T12:00:00.000Z
- Updated: 2026-09-14T17:05:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149640

FDA has issued Provention Bio a complete response letter on its BLA for teplizumab and its use for delaying clinical Type 1 diabetes in at-risk individuals. The letter stated that a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers to compare planned commercial product with drug product originating from 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.

Provention says 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 will be available later this quarter. The data will be analyzed by independent, unblinded third parties to maintain the integrity of this placebo-controlled trial, it says.

Additionally, 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.