FDA Approves Bimzelx for Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis

The FDA has approved Bimzelx (bimekizumab-bkzx) to treat adults with active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). The regulatory action marks the first approval of a medication for these three conditions that selectively inhibits interleukin (IL)-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.¹

“The approval of Bimzelx in the US across three new indications—active psoriatic arthritis, active [nr-axSpA] with objective signs of inflammation, and active ankylosing spondylitis—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,” said Emmanuel Caeymaex, executive vice president, head of Patient Impact and chief commercial officer, UCB, said in a press release. “In [PsA] and across the spectrum of axSpA, clinical study results and real-world experience outside the US have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to two years.”¹

Bimzelx, a humanized monoclonal IgG1 antibody, was developed to selectively inhibit IL-17A and IL-17F. The drug was approved by the FDA in October 2023 for adults with moderate to severe plaque psoriasis who are eligible for systemic therapies or phototherapies. It was the first and only approved psoriasis treatment that selectively inhibits IL-17A and IL-17F inhibitor.²

The newly approved indication of Bimzelx for adults with active PsA was based on findings from the Phase III BE OPTIMAL and BE COMPLETE trials. Investigators found that Bimzelx achieved the primary endpoint of American College of Rheumatology 50 (ACR50) response at week 16 compared with placebo, and also achieved all ranked secondary endpoints.

Efficacy findings were consistent across patients who are biologic-naïve and those who previously showed inadequate response to TNF inhibitor (TNFi) therapy. Investigators noted that the clinical responses achieved at week 16 were able to be sustained through week 52 in both BE OPTIMAL and BE COMPLETE, as well as an open-label extension trial as per the primary endpoint of ACR50, the ranked secondary endpoints of Psoriasis Area and Severity Index 90 (PASI90) minimal disease activity, and PASI100.

“Psoriatic arthritis can severely impact a person's quality of life. With joint pain and stiffness, daily activities can become burdensome. New treatment options are always a welcome addition, and they offer some renewed hope for relief from the symptoms and health impacts of PsA,” Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, said in a press release.¹

The approved indication for adults with active nr-axSpA with objective signs of inflammation, and active AS were based on results from the Phase III BE MOBILE 1 and BE MOBILE 2 studies. Across both analyses, Bimzelx achieved the primary endpoint of Assessment of SpondyloArthritis international Society 40 (ASAS40) response at week 16 vs. placebo, as well as all ranked secondary endpoints. Investigators noted consistent ASAS40 responses across treatment-naïve patients and who those had an inadequate response to TNFi-therapy. Further, clinical responses achieved at 16 weeks were able to be sustained across populations with nr-axSpA and AS through week 52 as assessed by ASAS40, ranked secondary endpoints, and other endpoints.

“In the Phase III clinical studies, patients treated with bimekizumab-bkzx saw improvements in signs and symptoms and key measures of disease activity at Week 16 which were sustained to one year and consistent across patients with non-radiographic axial spondyloarthritis and ankylosing spondylitis,” Atul Deodhar, MD, professor of Medicine and medical director of rheumatology clinics at the Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, said in the release. “The US rheumatology community welcomes the approval of bimekizumab-bkzx for use across the entire spectrum of axial spondyloarthritis, especially given that there are few options approved currently to treat both non-radiographic axial spondyloarthritis and ankylosing spondylitis.”¹

References

1. UCB Announces U.S. FDA Approvals for BIMZELX® (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis. News release. UCB. September 23, 2024. Accessed September 23, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-us-fda-approvals-for-bimzelxr-bimekizumab-bkzx-for-the-treatment-of-psoriatic-arthritis-non-radiographic-axial-spondyloarthritis-and-ankylosing-spondylitis

2. BIMZELX Approved by the U.S. FDA for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis. UCB. News release. October 18, 2023. Accessed September 23, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis