Provention Bio gets CRL on diabetes candidate novel BLA

7 July 2021

Shares of Provention Bio (Nasdaq: PRVB) closed own more than 26% at $6.11 yesterday, after the US biotech revealed a regulatory setback for its diabetes drug.

Provention announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the company's Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.

In the CRL 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.

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