UCB Reveals Prolonged FDA Clearance for BIMZELX to Address Inflammatory Autoimmune Disorders

UCB Reveals Prolonged FDA Clearance for BIMZELX to Address Inflammatory Autoimmune Disorders

UCB Reveals Prolonged FDA Clearance for BIMZELX to Address Inflammatory Autoimmune Disorders

This week, UCB, a biopharmaceutical company based in the U.S., revealed that the FDA has broadened its endorsement of BIMZELX (bimekizumab-bkzx) for treating four chronic immune-mediated inflammatory conditions. Originally receiving FDA approval in October 2023 for moderate-to-severe plaque psoriasis in adults, the drug’s new indication now includes adults experiencing active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA), and active ankylosing spondylitis (AS).

BIMZELX stands as the first and only IL-17A and IL-17F inhibitor approved in the U.S. for the management of autoimmune disorders. Both IL-17A and IL-17F belong to the interleukin family, significantly influencing inflammatory responses. Cytokines, such as these, are vital regulatory molecules in the immune system, overseeing the growth and functionality of various immune cells crucial for controlling inflammation. In individuals with autoimmune diseases, however, the regulation of these cytokines can become disrupted, leading to heightened inflammatory responses.

This humanized monoclonal antibody specifically binds to cytokines IL-17A, IL-17F, and IL-17AF, effectively blocking their interaction with receptors and inhibiting the release of pro-inflammatory cytokines and chemokines.

Emmanuel Caeymaex, Executive Vice President and Chief Commercial Officer of UCB, noted, “The FDA’s approval of BIMZELX in the U.S. for these three new indications underscores the clinical advantages of dual inhibition of IL-17A and IL-17F, offering more individuals with chronic inflammatory ailments a path to significant health improvements.”

“Clinical trials and real-world data obtained outside the U.S. indicate that BIMZELX can enable patients with psoriatic arthritis and across the range of axSpA to achieve substantial clinical responses that are both rapid and maintained for up to two years,” he added.

The green light for BIMZELX concerning active PsA came after the drug demonstrated achievement of primary and all secondary endpoints in two Phase 3 trials, BE OPTIMAL and BE COMPLETE. Patients afflicted with PsA tend to face the dual challenges of the chronic skin condition psoriasis alongside arthritis, leading to painful joint swelling. Those involved in the study received BIMZELX either after other treatments had failed or as their first biologic therapy. The outcomes indicated major improvements compared to placebo by Week 16, with these benefits sustained to Week 52.

Leah M. Howard, President and CEO of the National Psoriasis Foundation in the U.S., commented on BIMZELX’s approval: “Living with psoriatic arthritis can profoundly affect an individual’s quality of life. The associated joint pain and stiffness can make daily tasks challenging. New options in treatment are always embraced, bringing hope for alleviation from the symptoms of PsA.”

The FDA’s approvals for BIMZELX concerning active nr-axSpA and active AS were also determined based on two Phase 3 trials, BE MOBILE 1 and BE MOBILE 2, where both primary and all ranked secondary endpoints were met. Participants in the studies exhibited marked improvement in symptoms by Week 16 compared to those receiving a placebo, with benefits lasting until Week 52.

Seth Ginsberg, Co-Founder and President of the Global Health Living Foundation and CreakyJoints in the U.S., stated, “Individuals suffering with non-radiographic axial spondyloarthritis and ankylosing spondylitis often experience pain, stiffness, and fatigue, which can restrict their daily activities and overall quality of life. Having a new treatment option can help more patients accomplish their treatment objectives.”

BIMZELX is administered as a subcutaneous injection once every four weeks.