FDA CRL - Xbrane Biopharma AB

The FDA issued a Complete Response Letter (CRL) for Biologics License Application (BLA) 761187 to Xbrane Biopharma AB, indicating that the application cannot be approved in its present form. Key issues include significant deficiencies identified during pre-license inspections of two manufacturing facilities, necessitating satisfactory responses to FDA Form 483 findings. The company must also address non-compliance with regulatory requirements for prescribing information and carton/container labeling, specifically conforming to 21 CFR 201.56(a), (d), and 201.57 for content and format.

A substantial requirement is a comprehensive safety update. Xbrane Biopharma AB needs to provide detailed safety data from all studies, including retabulations of adverse events, reasons for study discontinuations, case report forms for serious adverse events and deaths, updated exposure information, and a summary of worldwide safety experience, evaluating any clinically meaningful differences from the U.S.-licensed reference product. The proposed proprietary name remains conditionally acceptable, contingent on resolving all application deficiencies.

To facilitate approval, Xbrane Biopharma AB must provide satisfactory responses to all facility inspection deficiencies, submit revised and compliant labeling, resubmit the proprietary name, and deliver a comprehensive safety update. The company has one year to resubmit the application or take other actions available under 21 CFR 601.3(b); failure to do so may result in the application being considered withdrawn.