FDA Accepts sBLA of Bimekizumab for 3 New Indications Including Psoriatic Arthritis

The supplemental Biologics License Applications (sBLAs) of 3 more indications for bimekizumab-bkzx (Bimzelx) were accepted by the US Food and Drug Administration (FDA) for review, according to an announcement by UCB.¹

The accepted submissions from FDA are for bimekizumab’s treatment of non-radiographic axial spondyloarthritis (nr-axSpA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Additionally, the announcement noted that an application for hidradenitis suppurativa (HS) has been formally lodged.

The sBLA which was accepted by the agency concerning PsA follows the positive findings resulting from two phase 3 studies that had suggested bimekizumab had demonstrated superiority over placebo in its alleviation of joint and skin manifestations across study cohorts which were both biologic-naïve and TNF inhibitor-inadequate.

The announcement also noted that efficacy had been sustained throughout the study’s duration of a year. In a similar vein, the FDA’s acceptance of the 2 sBLAs for nr-axSpA and AS, respectively, followed the positive findings drawn from their own corresponding phase 3 analyses.

Both conditions’ phase 3 studies had indicated bimekizumab's efficacy compared to that of the placebo in the alleviation of symptoms, disease signs, and disease activity during the 52-week research duration.

The fourth sBLA presented to the FDA for the drug’s treatment of HS is also noted by UCB officials as awaiting agency deliberations and approvals for each of its indications by the end of 2024. The FDA previously announced its approval of bimekizumab in October 2023 for patients with moderate-to-severe plaque psoriasis, specifically among adult individuals who may require phototherapy or systemic therapy.²

This approval by the FDA for psoriasis had been supported by the phase 3 results of the BE VIVID, BE READY, and BE SURE studies. These studies had all been randomized, multicenter, placebo and/or active compactor-controlled trials designed to evaluate the biologic’s efficacy and safety in a total patient population of 1480 psoriasis patients.

In the announcement of the FDA’s approval of bimekizumab, UCB officials had also noted a non-causal, potentially increased suicidal ideation risk for those treated with bimekizumab. The statement by UCB officials also noted that the biologic had an association with increased infection risk, mentioning that those with active tuberculosis should not be prescribed the drug.

If the drug were granted approval, bimekuzumab would represent the sole IL-17A and IL-17F inhibitor which is accessible by American patients for the treatment of the aforementioned medical conditions. The FDA’s deliberations and possible approvals in each of the earlier indications are set to occur prior to the end of 2024.¹

References

1. ^{UCB on Growth Path for a Decade Plus. UCB. February 28, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-on-growth-path-for-a-decade-plus. Date accessed: February 28, 2024.}
2. ^{Kunzmann K. FDA Approves Bimekizumab for Adults with Plaque Psoriasis. HCPLive. October 18, 2023. https://www.hcplive.com/view/fda-approves-bimekizumab-adults-plaque-psoriasis. Date accessed: February 28, 2024.}