FDA Approves Bimekizumab for PsA, nr-axSpA and AS

The U.S. Food and Drug Administration (FDA) has approved bimekizumab-bkzx for the treatment of adults with active psoriatic arthritis (PsA), adults with active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS).  

Bimekizumab is the first approved treatment for these 3 indications that is designed to selectively inhibit 2 key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F). These newly approved indications follow the first U.S. approval for bimekizumab in October 2023 for the treatment of moderate-to-severe plaque psoriasis among adults who are candidates for systemic therapy or phototherapy.

The FDA recommended dosage of bimekizumab for adult patients with active PsA, active nr-axSpA with objective signs of inflammation, and active AS is 160 mg by subcutaneous injection every 4 weeks. For PsA patients with coexistent moderate-to-severe plaque psoriasis, the dosage and administration are the same as for patients with moderate-to-severe plaque psoriasis. Bimekizumab is currently available for eligible patients.

The approval of bimekizumab for adult patients with active PsA is supported by data from the Phase 3 BE OPTIMAL and BE COMPLETE studies, in which bimekizumab met the primary endpoint of American College of Rheumatology 50 (ACR50) response at Week 16 versus placebo, and all ranked secondary endpoints. Consistent results were seen across both biologic-naïve patients and those who showed inadequate response to tumor necrosis factor (TNF) inhibitors. Clinical responses achieved at Week 16 were sustained to Week 52 in BE OPTIMAL and in BE COMPLETE, and its open-label extension, as assessed by ACR50 (primary endpoint), Psoriasis Area and Severity Index 90 (PASI90, ranked secondary endpoint), minimal disease activity ([MDA], ranked secondary endpoint) and PASI100, i.e., complete skin clearance.

The approvals of bimekizumab for adult patients with active nr-axSpA with objective signs of inflammation and active AS are supported by data from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies, respectively.  In both studies, bimekizumab met the primary endpoint of Assessment of SpondyloArthritis international Society 40 (ASAS40) response at Week 16 compared with placebo, and all ranked secondary endpoints. ASAS40 responses were consistent across TNFi-naïve and TNFi-inadequate responder patients. Clinical responses achieved at Week 16 were sustained in both patients with nr-axSpA and AS to Week 52 as assessed by ASAS40, ranked secondary and other endpoints.

Reference:

UCB announces US FDA approvals for Bimekizumab® (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. Press 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-bimekizumabr-bimekizumab-bkzx-for-the-treatment-of-psoriatic-arthritis-non-radiographic-axial-spondyloarthritis-and-ankylosing-spondylitis