European Medicine Agency accepts marketing authorization applications for bimekizumab in psoriatic arthritis and axial spondyloarthritis
UCB, a global biopharmaceutical company, today announced that the European Medicines Agency (EMA) has accepted for regulatory review the two marketing authorization applications for bimekizumab for the treatment of adult patients with active psoriatic arthritis (PsA), and adult patients with active axial spondyloarthritis (axSpA).
“These two regulatory applications in psoriatic arthritis and axial spondyloarthritis represent a significant milestone for bimekizumab as well as an important step towards expanding treatment options in the EU for these debilitating conditions. If approved for these two new indications, bimekizumab would be the first new treatment option in psoriatic arthritis and axial spondyloarthritis to selectively target IL-17F, in addition to IL-17A,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
The application in PsA is supported by data from the Phase 3 BE OPTIMAL and BE COMPLETE studies. (1,2) In both studies, bimekizumab met the primary and all ranked secondary endpoints, achieving clinically relevant improvements over placebo in both joint and skin symptoms, with efficacy outcomes consistent across the biologic-naïve and TNF-inhibitor inadequate responder (TNFi-IR) populations. (1,2) The application in active axSpA is based on data from the Phase 3 BE MOBILE 1 study in non-radiographic axSpA and the Phase 3 BE MOBILE 2 study in ankylosing spondylitis.3,4 Bimekizumab met the primary and all ranked secondary endpoints in both studies showing consistent improvements versus placebo in signs and symptoms across the full spectrum of axSpA, including non-radiographic axSpA and ankylosing spondylitis. (3,4) Across all four Phase 3 studies the safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals. (1,2,3,4)
In August 2021, bimekizumab received marketing authorization in countries of the European Union (EU)/European Economic Area (EEA) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. (5) The safety and efficacy of bimekizumab in PsA and axSpA have not been established, and it is not approved for use in PsA or axSpA by any regulatory authority worldwide.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin, with a prevalence of 0.02 percent to 0.25 percent of the population, and 6 percent to 41 percent of patients with psoriasis. (6) Symptoms include joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis), and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis). (7)
About Axial Spondyloarthritis
Axial Spondyloarthritis (axSpA), which includes both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA (r-axSpA), is a chronic, immune-mediated, inflammatory disease. (8) nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints. (8) AxSpA is a painful condition that primarily affects the spine and joints linking the pelvis and lower spine (sacroiliac joints). (8) The leading symptom of axSpA in the majority of patients is inflammatory back pain that improves with exercise, but not with rest.8 Other common clinical features include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease and dactylitis. (8) The overall prevalence of axSpA is 0.3 percent to 1.3 percent of adults. (9,10) Approximately half of all patients with axSpA are patients with nr-axSpA.8 axSpA onset usually occurs before the age of 45.8 Approximately 10 to 40 percent of patients with nr-axSpA progress to ankylosing spondylitis over 2 to 10 years. (8)
(1) McInnes I, Coates L, Landewé R.B.M. et al. Bimekizumab in bDMARD-Naïve Patients with Psoriatic Arthritis: 24-Week Efficacy & Safety from BE OPTIMAL, a Phase 3, Multicentre, Randomised, Placebo-Controlled, Active Reference Study. Abstract no: 5016. Presented at EULAR 2022.
(2) Merola JF, Mcinnes I, Ritchlin CT et al. Bimekizumab in Patients with Active Psoriatic Arthritis and an Inadequate Response to Tumour Necrosis Factor Inhibitors: 16-Week Efficacy & Safety from BE COMPLETE, a Phase 3, Multicentre, Randomised Placebo-Controlled Study. Abstract no: 2265. Presented at EULAR 2022.
(3) Deodhar A, van der Heijde D, Gensler LS et al. Bimekizumab in patients with active non-radiographic axial spondyloarthritis: 24-week efficacy and safety from BE MOBILE 1, a phase 3, multicentre, randomised, placebo-controlled study. Abstract no: POS 0939. Presented at EULAR 2022.
(4) van der Heijde D, Baraliakos X, Dougados M et al. Bimekizumab in patients with active ankylosing spondylitis: 24-week efficacy and safety from BE MOBILE 2, a phase 3, multicentre, randomised, placebo-controlled study. Abstract no: OP0019. Presented at EULAR 2022.
(5) BIMZELX® (bimekizumab) EU Summary of Product Characteristics.
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: September 2022.
(6) Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015; 41(4): 545–568.
(7) Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014; 74:423-441.
(8) Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25:S319-S330.