With three new indications, BIMZELX® (bimekizumab-bkzx) is the first and only IL-17A and IL-17F inhibitor approved in the U.S. for the treatment of four chronic immune-mediated inflammatory diseases
Approval in active PsA is supported by two Phase 3 studies in which BIMZELX showed statistically significant improvements vs. placebo at Week 16 in both joint and skin symptoms, across biologic-naïve and TNF inhibitor-inadequate responder populations, which were sustained to Week 52
Approvals in active nr-axSpA and active AS are supported by two Phase 3 studies, in which BIMZELX showed statistically significant improvements vs. placebo in signs and symptoms at Week 16, which were sustained to Week 52
ATLANTA, Sept. 23, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS).1 BIMZELX is the first approved treatment for these three indications that is designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).1 These newly approved indications follow the first U.S. approval for BIMZELX in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1
"The approval of BIMZELX in the U.S. across three new indications – active psoriatic arthritis, active non-radiographic axSpA with objective signs of inflammation, and active ankylosing spondylitis – 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, UCB. "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 FDA 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.1 For PsA patients with coexistent moderate-to-severe plaque psoriasis, the dosage and administration is the same as for patients with moderate-to-severe plaque psoriasis.1 BIMZELX is currently available for eligible patients.
BIMZELX for the treatment of adults with active psoriatic arthritis
"In Phase 3 clinical studies, the clinically meaningful and consistent clinical response in patients who had a previous inadequate response to TNF inhibitors, and in patients who were new to biologics, suggest that bimekizumab-bkzx has the potential to be an important new treatment option in our armamentarium for adults with psoriatic arthritis," said Joseph F. Merola, MD, MMSc, Professor, Dermatologist, Rheumatologist, and Investigator, BE OPTIMAL and BE COMPLETE. "The approval of bimekizumab-bkzx for the treatment of active psoriatic arthritis provides a new, differentiated treatment option for the rheumatology and dermatology communities."
The approval of BIMZELX for adult patients with active PsA is supported by data from the Phase 3 BE OPTIMAL and BE COMPLETE studies, in which BIMZELX met the primary endpoint of American College of Rheumatology 50 (ACR50) response at Week 16 versus placebo, and all ranked secondary endpoints.2,3 Consistent results were seen across both biologic-naïve and TNF inhibitor‑inadequate responder (TNFi-IR) populations.2,3 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 (other endpoint).4,5
"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," said Leah M. Howard, J.D., the President and CEO of the National Psoriasis Foundation, U.S.
BIMZELX for the treatment of adults with active nr-axSpA and active AS
"In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx saw improvements in signs and symptoms and key measures of disease activity at Week 16 which were sustained to one year and consistent across patients with non-radiographic axial spondyloarthritis and ankylosing spondylitis," said Atul Deodhar, MD, Professor of Medicine and Medical Director of Rheumatology Clinics at the Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, U.S. "The U.S. rheumatology community welcomes the approval of bimekizumab-bkzx for use across the entire spectrum of axial spondyloarthritis, especially given that there are few options approved currently to treat both non-radiographic axial spondyloarthritis and ankylosing spondylitis."
The approvals of BIMZELX 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.6,7 In both studies, BIMZELX met the primary endpoint of Assessment of SpondyloArthritis international Society 40 (ASAS40) response at Week 16 compared with placebo, and all ranked secondary endpoints.6,7 ASAS40 responses were consistent across TNFi-naïve and TNFi-inadequate responder patients.6,7 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.6,7
"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, Global Health Living Foundation and CreakyJoints, U.S. "A new treatment option offers the opportunity for more patients to reach their treatment goals."
Additional information about BIMZELX, including the full prescribing information, is available at UCB-USA.com/Innovation/Products/BIMZELX. For additional medical information, patient assistance or any other information, please call UCBCares® at 1-844-599-CARE (2273) or visit askucbcares.com. UCB's goal is to enable affordable access to our medicines for all people who need them, in a way which is sustainable for patients, society and UCB. Full affordability information can be found at UCB-USA.com/Affordability and www.BIMZELX.com.
