The complete response letter (CRL) for teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals reiterates the FDA’s concerns around the pharmacokinetics (PK) data for the antibody.
It also cites “additional considerations related to product quality” which Provention says it has already addressed, as well as deficiencies at a fill/finish facility operated by the company which will have to be resolved before approval.
Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.
