20 November 2024 - Approval is supported by data from the two Phase 3 studies, BE HEARD I and BE HEARD II, in which bimekizumab-bkzx improved the signs and symptoms of disease versus placebo at week 16, which were sustained to week 48.
UCB today announced that the US FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa.