UCB announced that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for BIMZELX® (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS). In addition, a second sBLA for the BIMZELX 2mL device presentations has also been accepted. These new regulatory milestones represent two of five sBLAs accepted by the FDA for BIMZELX this year, following the previously announced applications in psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS).

BIMZELX was approved in the U.S. in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1 BIMZELX is not approved in the U.S. for the treatment of moderate-to-severe HS, PsA, nr-axSpA, and AS, or for the 2mL device presentation. In the U.S., the efficacy and safety of BIMZELX in the treatment of moderate-to-severe HS, PsA, nr-axSpA, and AS have not been established and these are investigational indications. The sBLA in moderate-to-severe HS is supported by data from the Phase 3 BE HEARD I and BE HEARD II studies where BIMZELX demonstrated clinically meaningful improvements in HiSCR50 vs.

placebo at Week 16, the primary endpoint. A greater proportion of patients treated with BIMZELX vs. placebo also achieved HiSCR75 at Week 16, a key secondary endpoint.

In addition, over 48 weeks, improvements increased for patients in these studies. The safety profile of BIMZELX was consistent with previous studies with no new safety signals observed. The sBLA for the additional device presentations seeks approval of BIMZELX 2mL safety syringe and 2mL autoinjector with the aim of providing a second option to the currently approved 1mL presentations.