FDA Grants Bimekizumab-Bkzx Approval for Treatment of Chronic Immune-Mediated Inflammatory Diseases

The FDA granted approval to bimekizumab-bkzx (Bimzelx; Union Chimique Belge [UCB]), an interleukin 17A (IL-17A) and interleukin 17F (IL-17F) inhibitor, for the treatment of patients with psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS), according to a news release from global biopharmaceutical company UCB.¹

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The approval follows the acceptance of a supplemental biologics license application (sBLA) for bimekizumab-bkzx for these same indications in February 2024. An additional sBLA, for the treatment of hidradenitis suppurativa (HS), was submitted and accepted in April of 2024.^2,3

Additionally, in October 2023, the drug was approved by the FDA for adults with plaque psoriasis who are candidates for systemic therapy or phototherapy. With today’s announcement, bimekizumab-bkzx becomes the only IL-17A and IL-17F inhibitor approved in the United States for the treatment of these 3 new chronic immune-mediated inflammatory diseases as well as plaque psoriasis.¹

“The approval of [bimekizumab-bkzx] Bimzelxin the US across 3 new indications…highlights the clinical benefit of dual inhibition of both IL-17A and IL-17F for patients, and provides an opportunity for more people living with chronic inflammatory diseases to achieve meaningful outcomes,” Emmanual Caeymaex, executive vice president of UCB, said in the news release.¹

Bimekizumab-bkzx’s sBLA acceptance was based on results from the BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498) trials, that specifically evaluated the drug’s efficacy in adults with moderate to severe HS. These results, presented at the Conference of the European Hidradenitis Suppurativa, demonstrated high levels of clinical response with treatment from bimekizumab-bkzx.²

Administration of bimekizumab-bkzx is recommended to be 160 mg through a subcutaneous injection every 4 weeks. Now, data from multiple other trials confirms bimekizumab-bkzx’s short- and long-term efficacy for multiple other indications beyond HS.^1,2

In the phase 3 BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) studies, bimekizumab-bkzx met its primary end point of American College of Rheumatology 50 response at week 16 compared with a placebo in adults with PsA.¹

Importantly, results population were consistent in both TNF inhibitor inadequate responder (TNFi-IR) and biologic-naïve cohorts. Responses that were achieved at week 16 were sustained to week 52 in both trials and BE COMPLETE’s open-label extension.¹

Regarding the nr-axSpA and AS populations, data from the phase 3 BE MOBILE 1 (NCT03928704) and BE MOBILE 2 (NCT03928743) studies supported bimekizumab-bkzx’s approval. In each study, the drug met the primary end point of Assessment of Spondyloarthritis International Society 40 response at week 16 compared with placebo, which was sustained until week 52.¹

“People living with nr-axSpA and AS experience pain, stiffness and fatigue that can limit their daily activities, ability to work, and quality of life,” Seth Ginsberg, co-founder and president, Global Health Living Foundation, said. “A new treatment option offers the opportunity for more patients to reach their treatment goals.”¹

REFERENCES

1. UCB. UCB announces US FDA approvals for Bimzelx (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. News Release. Released September 23, 2024. Accessed September 23, 2024.

2. McGovern G. FDA accepts sBLA for bimekizumab-bkzx in 3 new spondyloarthritides indications. Pharmacy Times. Published February 28, 2024. Accessed September 23, 2024. https://www.pharmacytimes.com/view/fda-accepts-sbla-for-bimekizumab-bkzx-in-3-new-spondyloarthritides-indications

3. Gallagher A. FDA accepts sBLA for bimekizumab-bkzx in hidradenitis suppurativa treatment. Pharmacy Times. Published April 4, 2024. Accessed September 23, 2024. https://www.pharmacytimes.com/view/fda-accepts-sbla-for-bimekizumab-bkzx-in-hidradenitis-suppurativa-treatment