UCB Announces U.S. FDA Approvals for BIMZELX® (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis

U.S. FDA Approves BIMZELX® for Chronic Inflammatory Diseases

UCB, a global biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) approval of BIMZELX® (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). BIMZELX is the first treatment designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), key cytokines driving inflammatory processes.

Clinical Trials and Efficacy

The approval for active PsA is supported by data from the Phase 3 BE OPTIMAL and BE COMPLETE studies, where BIMZELX showed statistically significant improvements in joint and skin symptoms at Week 16, sustained to Week 52. For nr-axSpA and AS, the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies demonstrated significant improvements in signs and symptoms at Week 16, also sustained to Week 52.

Dosage and Administration

The recommended dosage of BIMZELX for adult patients with active PsA, active nr-axSpA with objective signs of inflammation, and active AS is 160 mg by subcutaneous injection every four 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.

Impact on Patients

Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer at UCB, highlighted the clinical benefit of dual inhibition of both IL-17A and IL-17F for patients, offering an opportunity for more people living with chronic inflammatory diseases to achieve meaningful outcomes. Clinical study results and real-world experience outside the U.S. have shown that BIMZELX can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to two years.

Safety Information

BIMZELX may increase the risk of suicidal ideation and behavior, infections, and liver biochemical abnormalities. Patients should be monitored for these risks, and treatment should be adjusted accordingly. The most common adverse reactions include upper respiratory tract infections, oral candidiasis, headache, and diarrhea.

This approval marks a significant advancement in the treatment of chronic immune-mediated inflammatory diseases, providing a new, differentiated treatment option for the rheumatology and dermatology communities.