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FDA issues complete response for PRV 031 in type 1 diabetes.- Provention Bio

Read time: 1 mins
Last updated:29th Jul 2021
Published:7th Jul 2021
Provention Bio announced that the FDA has issued a Complete Response Letter (CRL) for the Company's Biologics License Application (BLA) for PRV 031 (teplizumab) for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. In the CRL, received late evening on July 2nd, 2021, the FDA 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 historic clinical trials had failed to show PK comparability.
Condition: Diabetes Type 1
Type: drug
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