On 7 June 2023, Belgian biopharmaceutical powerhouse UCB announced that the European Commission granted marketing approval for Bimzelx (bimekizumab), its humanised monoclonal IgG1 antibody, which exerts simultaneous selective inhibition of interleukin 17A (IL-17A) and IL-17F, for adults with active psoriatic arthritis (PsA), and for adults with active non-radiographic axial spondyloarthritis (axSpA) who exhibited intolerance to non-steroidal anti-inflammatory drugs. According to the reported Phase III clinical data, Bimzelx demonstrated superior long-term disease control and significant clinical improvements in the signs and symptoms of PsA and axSpA in patients when compared to the respective placebo groups (UCB, press release, 7 May 2023).
According to an article by Mehreen Soomiro and colleagues in Arthritis & Rheumatology, PsA is a chronic immune-mediated dermatological condition that affects the peripheral and axial skeleton, including the skin and nails, impacting 14% to 30% of psoriasis patients. Similarly, and equally debilitating, both radiographic and non-radiographic axSpA are marked by pain, stiffness, restricted movement in the axial skeleton, and a debilitated quality of life. UCB’s Bimzelx represents the first and only IL-17A and IL-17F inhibitor to be approved in the EU for individuals with active PsA and axSpA, following its European approval as a treatment option for moderate-to-severe plaque psoriasis (PsO) in August 2021, and its first marketing authorization for PsA and axSpA worldwide. Following an intravenous or subcutaneous administration of Bimzelx 160mg, the agent selectively targets and binds with IL-17A and IL-17F, key drivers and inflammatory cytokines involved in the pathogenesis of both conditions, offering healthcare professionals and patients a novel treatment option.
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In PsA, bimekizumab is indicated alone or in combination with methotrexate for the treatment of adults who have had an intolerance to one or more disease-modifying antirheumatic drugs. In non-radiographic axSpA, bimekizumab is approved for the treatment of adults with objective signs of inflammation as evidenced by elevated C-reactive protein and/or magnetic resonance imaging who responded inadequately to non-steroidal anti-inflammatory drugs.
The European Commission based its approval of the drug for adults with active PsA on results from UCB’s randomised, double-blind, placebo-controlled Phase III BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) studies, and for adults with active axSpA on results from UCB’s randomised, double-blind, placebo-controlled Phase III BE MOBILE 1 (NCT03928704) and BE MOBILE 2 (NCT03928743) studies. The BE OPTIMAL and BE COMPLETE studies showed bimekizumab’s ability to improve joint and skin symptoms compared to the trialled placebo cohort across biologic-naïve and tumour necrosis factor (TNF) inhibitor-inadequate responder populations, meeting the primary endpoint of American College of Rheumatology (ACR) 50 and all ranked secondary endpoints at Week 16, with clinical responses maintained over 52 weeks. In the BE MOBILE 1 and 2 studies, the agent demonstrated improvements in the signs, symptoms, and disease activity of axSpA when compared to the placebo. Bimzelx met the primary endpoint of Assessment in Spondyloarthritis International Society (ASAS) 40 response criteria and all secondary endpoints at Week 16 when compared to the placebo groups, with responses being consistent across both TNF-inhibitor-naïve and inadequate responder patients and maintained over 52 weeks. Bimzelx has consistently shown a favourable safety profile in the conducted clinical studies, with the most frequently reported adverse events being nasopharyngitis, upper respiratory tract infection, headache, diarrhoea, oral candidiasis, pharyngitis, and hypertension.
The extended European approval of UCB’s bimekizumab in these indications represents a significant milestone for the company in its commitment to address unmet patient needs and improve the quality of life for those affected by PsA and axSpA, building on the momentum created since its first approval in PsO. Bimekizumab’s distinctive mechanism of action as an IL-17A and IL-17F inhibitor, in addition to its demonstrated efficacy in clinical studies, stations it as an important treatment option in these therapeutic areas.
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According to GlobalData’s Pharma Intelligence Center Drugs Database, with an analyst consensus global sales forecast of $2.4bn by 2029, Bimzelx is set to become a blockbuster for the treatment of PsA and axSpA, directly competing against formidable and well-entrenched biologic agents in the space, including forging a rivalry with AbbVie’s Humira (adalimumab) and Novartis’s Cosentyx (secukinumab).
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Reports
Likelihood of Approval and Phase Transition Success Rate Model – Bimekizumab in Psoriatic Arthritis
Overall, GlobalData understands that the consistent high disease control achieved with Bimzelx as demonstrated by the positive clinical trial results, and its expanded indication use in the European arena, highlights its potential to improve patient outcomes and raise standards of care of PsO, PsA, and axSpA patients, amongst others.
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