FDA Approves BIMZELX for Psoriatic Arthritis, Axial Spondyloarthritis, and Ankylosing Spondylitis

BRUSSELS, Belgium, September 23, 2024 – UCB, a prominent biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for BIMZELX® (bimekizumab-bkzx) to treat adults with several chronic inflammatory conditions. These include active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). Notably, bimekizumab-bkzx is the first treatment approved for these three conditions that targets both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two cytokines that play a central role in the inflammatory process.

Previously, BIMZELX received FDA approval in October 2023 for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Emmanuel Caeymaex, Executive Vice President at UCB, emphasized the significance of this expanded approval, noting that it underscores the clinical benefits of dual inhibition of IL-17A and IL-17F. He added that this approval could help more patients with chronic inflammatory diseases achieve meaningful clinical outcomes.

For administration, the FDA recommends a dosage of 160 mg bimekizumab by subcutaneous injection every four weeks for adults with active PsA, active nr-axSpA with objective inflammation signs, and active AS. For PsA patients with moderate to severe plaque psoriasis, the same dosage and administration guidelines apply.

Bimekizumab was tested in Phase 3 clinical studies, showing meaningful and consistent clinical responses. These studies included patients who had previously shown inadequate response to TNF inhibitors and those new to biologics. According to Dr. Joseph F. Merola, a professor and investigator in the BE OPTIMAL and BE COMPLETE studies, the clinical responses achieved at Week 16 were sustained up to 52 weeks. This was validated through various measures, including the American College of Rheumatology 50 (ACR50) response, Psoriasis Area, and Severity Index 90 (PASI90), and complete skin clearance (PASI100).

Moreover, the approval of bimekizumab for active nr-axSpA and active AS is supported by data from the BE MOBILE 1 and BE MOBILE 2 studies. These studies demonstrated that patients treated with bimekizumab experienced improvements in disease activity and symptoms that were sustained for up to one year. Dr. Atul Deodhar, a professor and medical director at Oregon Health & Science University, highlighted that the clinical responses were consistent across both TNFi-naïve and TNFi-inadequate responder patients.

Psoriatic arthritis (PsA) is a chronic systemic inflammatory condition affecting both joints and skin, with symptoms that include joint pain and stiffness, skin plaques, and inflammation at the site where tendons or ligaments insert into the bone. Approximately 30 percent of people living with psoriasis develop PsA.

Axial spondyloarthritis (axSpA), encompassing non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), is an inflammatory disease primarily affecting the spine and sacroiliac joints. The primary symptom is inflammatory back pain, which improves with exercise but not with rest. Other common features include uveitis, enthesitis, peripheral arthritis, psoriasis, and inflammatory bowel disease.

Bimekizumab-bkzx is a humanized IgG1 monoclonal antibody that selectively targets IL-17A and IL-17F cytokines. Elevated levels of these cytokines are found in psoriatic lesions, which underscores the therapeutic significance of bimekizumab in addressing these chronic inflammatory conditions.

UCB, headquartered in Brussels, Belgium, is focused on developing innovative treatments for severe diseases of the immune and central nervous systems. With a global workforce of around 9,000 employees, UCB generated revenue of €5.3 billion in 2023.