FDA accepts sBLA's for Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa and additional 2mL device presentations- UCB
UCB, announced that the FDA 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 bimekizumab-bkzx 2mL device presentations has also been accepted.
“We are excited to share the progress on our FDA applications. The most recent sBLA seeks approval for bimekizumab-bkzx in moderate to severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of bimekizumab to more patients living with IL-17 mediated diseases,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions, and Head of U.S., UCB. “In addition, the sBLA for the 2mL device presentations aims to offer increased convenience for patients. Today, one dose of bimekizumab in moderate to severe plaque psoriasis, is administered as two 1mL injections. Approval of the 2mL device presentations would mean that patients would have an alternative one injection regimen option.”
These new regulatory milestones represent two of five sBLAs accepted by the FDA for bimekizumab-bkzx in 2024, following the previously announced applications in psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). Bimzelx was first 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. Bimekizumab-bkzx 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 bimekizumab-bkzx in the treatment of moderate to severe HS, PsA, nr-axSpA and AS have not been established and these are investigational indications only.
The sBLA in moderate to severe HS is supported by data from the Phase III BE HEARD I and BE HEARD II studies where bimekizumab-bkzx demonstrated clinically meaningful improvements in HiSCR50 vs. placebo at Week 16, the primary endpoint. A greater proportion of patients treated with bimekizumab 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 bimekizumab-bkzx was consistent with previous studies with no new safety signals observed.
The sBLA for the additional device presentations seeks approval of bimekizumab-bkzx 2mL safety syringe and 2mL autoinjector with the aim of providing a second option to the currently approved 1mL presentations.
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