European Medicine Agency Accepts Marketing Authorization Applications for Bimekizumab in Psoriatic Arthritis and Axial Spondyloarthritis

Brussels (Belgium), 20th September 2022 – 07:00 (CEST) – 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.

Notes to editors:

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

About BE OPTIMAL
BE OPTIMAL is a randomized, multicenter, double-blind, placebo-controlled, active reference (adalimumab), parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active PsA, who are biologic disease-modifying anti rheumatic drug naïve. For additional details on the study, visit BE OPTIMAL on clinicaltrials.gov.¹¹

About BE COMPLETE
BE COMPLETE was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in adults with active PsA and an inadequate response to tumor necrosis factor inhibitors (TNFi-IR).¹² All enrolled study participants had a history of inadequate response (lack of efficacy after at least three months of therapy at an approved dose) or intolerance to treatment with one or two TNFi for either PsA or psoriasis. For additional details on the study, visit BE COMPLETE on clinicaltrials.gov.¹²

About BE MOBILE 1    
BE MOBILE 1 is a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active nr-axSpA. For additional details on the study, visit BE MOBILE 1 on clinicaltrials.gov.¹³

About BE MOBILE 2
BE MOBILE 2 is a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active AS. For additional details on the study, visit BE MOBILE 2 on clinicaltrials.gov.¹⁴

About BIMZELX^®▼(bimekizumab)
BIMZELX® (bimekizumab) is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.^5,15 In August 2021, bimekizumab was approved in the EU/EEA and Great Britain for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.^5,16  In January 2022, bimekizumab received marketing authorization in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma in patients who are not sufficiently responding to existing treatments.¹⁷  In February and March 2022, bimekizumab received marketing authorization in Canada and Australia respectively for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.^18,19

BIMZELX^®  ▼ (bimekizumab) EU/EEA Important Safety Information in Psoriasis
The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5 percent) (most frequently nasopharyngitis) and oral candidiasis (7.3 percent). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headache, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.

Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis). 
Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be administered in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB and patients receiving bimekizumab should be monitored for signs and symptoms of active TB. 

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated. Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated. 

Live vaccines should not be given in patients treated with bimekizumab.

Please consult the summary of product characteristics in relation to other side effects, full safety and prescribing information. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf

EU summary of product characteristics date of revision March 2022
Last accessed: June 2022

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions 

For further information, contact UCB: 

Investor Relations
Antje Witte
T +32.2.559.94.14 
email antje.witte@ucb.com     

Corporate Communications
Laurent Schots 
T +32.2.559.92.64 
email laurent.schots@ucb.com

Brand Communications
Eimear O’Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com 

About UCB 
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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References

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.
9.    Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res. 2012;64(6):905-910.
10.    Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyloarthritis in the UK: a cross-sectional cohort study. BMC Musculoskelet Disord. 2015;21(16):392.
11.    ClinicalTrials.gov. A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects with Active Psoriatic Arthritis (BE OPTIMAL). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03895203?term=BE+OPTIMAL&draw=2&rank=1 Last accessed: September 2022.
12.    ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects with Active Psoriatic Arthritis (BE COMPLETE). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03896581 Last accessed: September 2022.
13.    ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (BE MOBILE 1). Available at: https://clinicaltrials.gov/ct2/show/NCT03928704.  Last accessed: September 2022.
14.    ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis (BE MOBILE 2). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03928743. Last accessed: September 2022.
15.    Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001.
16.    BIMZELX® (bimekizumab) GB Summary of Product Characteristics. 
https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833. Last accessed: September 2022.
17.    Pharmaceuticals and Medical Devices Agency https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html. Last accessed: August 2022.
18.    BIMZELX (bimekizumab) Canada Product Monograph. Available at: https://pdf.hres.ca/dpd_pm/00064702.PDF. Last accessed: September 2022.
19.    BIMZELX (bimekizumab) Australia. Available at: https://www.tga.gov.au/apm-summary/bimzelx. Last accessed: September 2022.