The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted marketing application submissions for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis
- The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted marketing application submissions for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis
- This accepted submission is supported by a robust data package including three Phase 3 studies which demonstrate superiority of bimekizumab to placebo, Stelara® (ustekinumab) and Humira® (adalimumab) in achieving skin clearance at week 16
BRUSSELS, Sept. 22, 2020 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that the FDA and EMA have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.
“After a series of positive Phase 3 data readouts, we are delighted to announce that the U.S. FDA and EMA have accepted our applications to file bimekizumab as a potential new treatment for psoriasis. This milestone brings us one step closer to being able to offer a meaningful new treatment option for people living with this debilitating disease. UCB is committed to providing innovative solutions for people living with serious inflammatory diseases like psoriasis,” said Emmanuel Caeymaex, Executive Vice President Immunology Solutions and Head of US, UCB.
The marketing application submissions for bimekizumab are based on data from a global Phase 3 clinical development program in psoriasis.1,2,3 All Phase 3 studies met their primary endpoints, demonstrating that bimekizumab-treated patients achieved superior skin clearance, at week 16, compared to those who received placebo and Humira® (adalimumab) as measured by the Psoriasis Area and Severity Index (PASI 90) and an Investigator Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1).1,2,3
All the Phase 3 studies met their ranked secondary endpoints.1,2,3 Two studies demonstrated superior total skin clearance at week 16, as measured by PASI 100, confirming the superiority of bimekizumab over existing biologic treatments Stelara® (ustekinumab) and adalimumab.2,3 Furthermore, bimekizumab was superior to placebo, ustekinumab and adalimumab in achieving rapid response, defined as PASI 75 at week 4.3 Clinical responses were maintained up to one year in all studies.1,2,3 The safety profile of bimekizumab continues to be consistent with earlier clinical studies with no new safety signals identified.1,2,3,4,5
The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide. Bimekizumab is currently also being evaluated in Phase 3 trials for potential indications in psoriatic arthritis,6,7 ankylosing spondylitis,8 non-radiographic axial spondyloarthritis9 and hidradenitis suppurativa.10,11
About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.12 IL-17F has overlapping biology with IL-17A and drives inflammation independently to IL-17A.13,14,15,16,17 Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone.10,11 The safety and efficacy of bimekizumab are being evaluated across multiple disease states as part of a robust clinical program.
About BE VIVID
BE VIVID is a randomized, 52-week, double-blind, placebo- and active-controlled study designed to assess the efficacy and safety of bimekizumab in adult patients with moderate to severe chronic plaque psoriasis.18 BE VIVID enrolled 570 participants with chronic plaque psoriasis for at least six months prior to screening and with an affected body surface area of at least 10 percent and PASI of at least 12 and IGA score >=3 on a 5-point scale.19
The co-primary endpoints of the study were PASI 90 response (defined as a patient who achieves 90 percent improvement from baseline in the PASI score) at week 16, and Investigators’ Global Assessment (IGA) 0 or 1 response (defined as clear or almost clear with at least a 2-category improvement relative to baseline) at week 16.19 UCB announced topline findings from BE VIVID in October 2019. For additional details on the study, visit BE VIVID on clinicaltrials.gov.19
About BE READY
BE READY is a Phase 3, randomized, 56-week, double-blind, placebo-controlled study, with an initial treatment period followed by a randomized-withdrawal period, designed to assess the efficacy and safety of bimekizumab in adult patients with moderate to severe chronic plaque psoriasis.19 BE READY enrolled 435 participants with chronic plaque psoriasis for at least six months prior to screening and with an affected body surface area of at least 10 percent and PASI of at least 12 and IGA score >=3 on a 5-point scale.20
The co-primary endpoints of the study were PASI 90 response (defined as a patient who achieves a 90 percent improvement in PASI) and IGA response (defined as clear or almost clear with at least a two-category improvement relative to baseline) at week 16.20 UCB announced topline findings from BE READY in November 2019. For additional details on the study, visit BE READY on clinicaltrials.gov.20
About BE SURE
BE SURE is a Phase 3, randomized, double-blind study comparing bimekizumab to adalimumab in adult patients with moderate to severe chronic plaque psoriasis; the active-controlled initial treatment period of 24 weeks is followed by a dose-blind maintenance treatment period until week 56.20 BE SURE enrolled 480 participants with chronic plaque psoriasis for at least six months prior to screening and with an affected body surface area of at least 10 percent, PASI of at least 12 and IGA score equal to or greater than three on a five-point scale.18
The co-primary endpoints of the study were PASI 90 response (defined as a patient who achieves a 90 percent improvement in PASI) and IGA response (defined as clear or almost clear with at least a two-category improvement relative to baseline) at week 16.18 For additional details on the study, visit BE SURE on clinicaltrials.gov.18 UCB announced topline findings from BE SURE in December 2019. For additional details, visit: BE SURE on UCB.com.
Humira® is a registered trademark of AbbVie, Inc; Stelara® is a registered trademark of Johnson & Johnson.
About Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin. This skin condition affects men and women of all ages and ethnicities.21 Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery scales; dry, cracked skin that may bleed; and thickened, pitted or ridged nails.22
Psoriasis affects nearly three percent of the population, or about 125 million people worldwide.21 Unmet needs remain in the treatment of psoriasis. A population-based survey identified that approximately 30 percent of psoriasis patients reported that their primary goals of therapy, including keeping symptoms under control, reducing itching and decreasing flaking, were not met with their current treatment.23 Psoriasis has a considerable psychological and quality of life impact, potentially affecting work, recreation, relationships, sexual functioning, family and social life.24
UCB Response to COVID-19
UCB is committed to helping those impacted by the novel coronavirus, COVID-19. This includes helping patients maintain access to and answering any questions about UCB medicines. We are also working closely with regulatory authorities to ensure the safety of all clinical trial participants and investigators, maintain compliance with good clinical practice, and minimize risks to trial integrity. The evolving COVID-19 pandemic has placed tremendous strain on medical healthcare systems worldwide as they focus on the ongoing extraordinary medical emergency. Taking this into consideration, UCB has taken measures to protect patients, healthcare providers, our employees, and the communities we serve around the world.
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 more than 7,600 people in approximately 40 countries, the company generated revenue of € 4.9 billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
Forward looking statements UCB
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Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.
UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.
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For further information, UCB:
Corporate Communications
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Media Relations, UCB
T+32.2.559.92.64,
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Immunology Communications, UCB
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_____________________________
1 Gordon K, Foley P, Krueger J, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe plaque psoriasis: results from BE READY, a 56-week Phase 3, randomized, double-blinded, placebo-controlled study with randomized withdrawal. Late-breaking research; Abstract at AAD 2020.
2 Reich K, Papp KA, Blauvelt A, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe plaque psoriasis: results from BE VIVID, a 52-week Phase 3, randomized, double-blinded, ustekinumab- and placebo-controlled study. Late-breaking research; Abstract at AAD 2020.
3 UCB Pharma Data on File January 2019.
4 UCB Pharma Data on File September 2020.
5 Papp K, Merola J, Gottlieb A, et al. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial. J Am Acad Dermatol. 2018;79(2):277-286.e10.
6 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/NCT3896581. Last accessed: September 2020.
7 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. Last accessed: September 2020.
8 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 2020.
9 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://www.clinicaltrials.gov/ct2/show/NCT03928704. Last accessed: September 2020.
10 ClinicalTrials.gov. A study to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (BE HEARD I). Available at: https://www.clinicaltrials.gov/ct2/show/NCT04242446. Last accessed: September 2020.
11 ClinicalTrials.gov. A study to test the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (BE HEARD II). Available at: https://www.clinicaltrials.gov/ct2/show/NCT04242498. Last accessed: September 2020.
12 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.
13 Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses by IL-17F. J Exp Med. 2008;205(5):1063–1075.
14 Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fold: structure and activity of a novel cytokine, IL-17F, and implications for receptor binding. Embo J. 2001;20(19):5332–5341.
15 van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expression pattern of interleukin 17A (IL-17A), IL-17F and their receptors in synovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possible explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther. 2014;16(4):426.
16 Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-17A and IL-17F provides evidence of IL-17F contribution to chronic inflammation in disease-relevant cells. Abstract THU0038. Ann Rheum Dis. 2017;76(Suppl 2):213.
17 Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.
18 ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE VIVID). Available at: https://clinicaltrials.gov/ct2/show/NCT03370133. Last accessed: September 2020.
19 ClinicalTrials.gov. A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY). Available at: https://clinicaltrials.gov/ct2/show/NCT03410992. Last accessed: September 2020.
20 Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03412747. Last accessed: September 2020.
21 National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Last accessed: September 2020.
22 International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/our-cause/. Last accessed: September 2020.
23 Lebwohl MG, Kavanaugh A, Armstrong AW et al. US Perspectives in the Management of Psoriasis and Psoriatic Arthritis: Patient and Physician Results from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016;17(1):87-97.
24 Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130.
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