UCB refiles BLA for bimekizumab with US FDA

Belgium’s largest drugmaker UCB (Euronext Brussels: UCB) said yesterday it has resubmitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.

The resubmission follows the receipt of a Complete Response Letter (CRL) from the FDA in May this year, which stated that certain pre-license inspection observations must be resolved before the application may be approved. The CRL was not due to efficacy or safety. That delay came on top of a prior deferral, in October 2021, with the FDA at that time blaming COVID-19-related travel restrictions for its inability to reach a verdict.

The FDA is expected to determine whether the resubmission constitutes a complete response, and if so, the classification of the resubmission will be communicated.