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Teplizumab is being evaluated to delay type 1 diabetes. The PDUFA date is August 17, 2022.
Provention Bio has resubmitted and the FDA has accepted the biologics license application (BLA) for teplizumab for the delay of type 1 diabetes (T1D). The FDA has assigned a user fee goal date of August 17, 2022. If approved, teplizumab, an anti-CD3 monoclonal antibody, will be the first disease-modifying therapy for type 1 diabetes.
In July 2021, the FDA had issued a complete response letter for the therapy, indicating they wanted to see 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 historic clinical trials had failed to show PK comparability.
The company has competed the required study assessing pharmacokinetic comparability. During a pre-BLA meeting in January, the FDA proposed, and the company agreed, to use PK modeling to adjust the 14-day dosing regimen match the exposure of clinical material used in prior clinical trials by ensuring that the 90% confidence intervals for relevant PK parameters fall within the target 80% to 125% range.
Additionally, a separate Type A meeting with the FDA during which several considerations related to product quality that were cited in the CRL were discussed.
Provention Bio is currently evaluating teplizumab in patients with newly diagnosed insulin-dependent type 1 diabetes in the phase 3 PROTECT study. The company reached the target enrollment of 300 patients during the third quarter of 2021 and expect to report top-line data from the from this study in the second half of 2023.