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FDA Accepts UCB’s sBLA for Bimzelx in HS

 

The U.S. Food and Drug Administration (FDA) recently accepted UCB’s supplemental Biologics License Application (sBLA) for bimekizumab-bkzx (Bimzelx, UCB), an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS). Jeffrey Stark, MD, VP and Head of Medical Immunology, UCB, discusses the data supporting the sBLA and the unmet need that remains among HS patients. FDA action is expected by the end of the year. The European Commission (EC) granted marketing authorization for bimekizumab (Bimzelx, UCB) for the treatment of active moderate to severe HS in adults with an inadequate response to conventional systemic therapy.