The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for bimekizumab (UCB) for the treatment of moderate to severe plaque psoriasis in adults.

Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F. The BLA is supported by data from the phase 3 BE VIVID, BE READY, and BE SURE studies that evaluated the efficacy and safety of bimekizumab. Patients enrolled in these studies had moderate to severe chronic plaque psoriasis for at least 6 months with an affected body surface area of at least 10%, Psoriasis Area and Severity Index (PASI) of at least 12, and Investigator’s Global Assessment (IGA) score equal to or greater than 3 on a 5-point scale. 

BE VIVID compared bimekizumab to placebo and ustekinumab in 570 patients for 52 weeks; BE READY compared bimekizumab to placebo in 435 patients for 56 weeks; and BE SURE compared bimekizumab to adalimumab in 480 patients for 56 weeks. The co-primary end points for all studies were PASI 90 response and an IGA response of clear or almost clear at week 16.

Results showed that patients treated with bimekizumab achieved superior skin clearance at week 16 when compared with those who received placebo or adalimumab. Bimekizumab was also associated with superior total skin clearance (PASI 100) at week 16 when compared with ustekinumab and adalimumab. Moreover, bimekizumab was found to be superior to placebo, ustekinumab and adalimumab in achieving rapid response, defined as PASI 75 at week 4. Clinical responses were maintained in all studies for up to 1 year.

Additionally, the Company recently announced results from the BE RADIANT trial, which compared bimekizumab to secukinumab, an IL-17A antagonist. Results showed that treatment with bimekizumab was superior to secukinumab with regard to complete skin clearance (PASI 100 response) at week 16.

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Bimekizumab is also being investigated in phase 3 trials for the treatment of psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa.

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UCB achieves important regulatory milestone for bimekizumab. Accessed September 22, 2020.