UCB announces extended FDA approvals for BIMZELX for the treatment of inflammatory autoimmune diseases

The U.S. biopharma company UCB announced this week that the FDA has extended its approval of BIMZELX (bimekizumab-bkzx) for the treatment of four chronic immune-mediated inflammatory diseases. The FDA first approved BIMZELX in October 2023​ for the treatment of moderate-to-severe plaque psoriasis in adults and has now extended its approval to adults who suffer from active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA), or active ankylosing spondylitis (AS).

BIMZELX is the first and only IL-17A and IL-17F inhibitor approved in the U.S. for treating autoimmune diseases. IL-17A and IL-17F are interleukins, part of the cytokine family, that play a large role in inflammatory processes. Cytokines are important players in the immune system and control the growth and activity of different immune cells to control inflammation in the body. In people with autoimmune diseases, however, cytokines become dysregulated, resulting in increased inflammation.

As a humanized monoclonal antibody, BIMZELX can selectively bind to the cytokines IL-17A, IL17F, and IL17AF and prevent them from interacting with a receptor and, in turn, preventing the release of proinflammatory cytokines and chemokines.

"The approval of BIMZELX in the U.S. across three new indications [...] 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 of UCB, in a press statement.

"In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the U.S. have highlighted that BIMZELX can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to two years."

The approval of BIMZELX in active PsA followed two Phase 3 studies –  BE OPTIMAL and BE COMPLETE – after the drug met the primary and all secondary endpoints in both studies. People with PsA suffer from the chronic skin condition psoriasis coupled with arthritis, which causes joint swelling and pain. Participants received BIMZELX after other therapies failed or were given a biologic for the first time. The results showed significant improvements in joint and skin symptoms versus placebo at Week 16. Improvements were sustained to Week 52.

Leah M. Howard, President and CEO of the National Psoriasis Foundation, U.S. commented on the BIMZELX approval in a press release: "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."

The FDA approvals of BIMZELX in active nr-axSpA and active AS are also based on two Phase 3 studies – BE MOBILE 1 and BE MOBILE 2 – where the primary and all ranked secondary endpoints were met. At Week 16, study participants showed significant improvements in symptoms versus participants who only received a placebo. Improvements remained to Week 52.

"People living with non-radiographic axial spondyloarthritis and ankylosing spondylitis experience pain, stiffness and fatigue that can limit their daily activities, ability to work, and quality of life," said Seth Ginsberg, Co-Founder and President of the Global Health Living Foundation and CreakyJoints, U.S., in a press release. "A new treatment option offers the opportunity for more patients to reach their treatment goals."

BIMZELX is given as a subcutaneous injection every four weeks.