UCB Receives Positive CHMP Opinion Recommending Approval of BIMZELX®* (bimekizumab) in the EU for the Treatment of Adults with Moderate to Severe Plaque Psoriasis 

UCB Receives Positive CHMP Opinion Recommending Approval of BIMZELX^®* (bimekizumab) in the EU for the Treatment of Adults with Moderate to Severe Plaque Psoriasis 

• The positive CHMP opinion is supported by data from three Phase 3 studies where bimekizumab demonstrated superior levels of skin clearance compared to placebo, ustekinumab and adalimumab
• If approved by the European Commission, bimekizumab will be the first approved treatment for moderate to severe plaque psoriasis that is designed to selectively and directly inhibit both IL-17A and IL-17F
• The European Commission is expected to deliver its decision on the marketing authorization of bimekizumab, under the trade name BIMZELX^®*, in approximately two months

UCB, a global biopharmaceutical company, announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending granting a marketing authorization for BIMZELX^®* (bimekizumab), an investigational IL-17A and IL-17F inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

“This positive CHMP opinion is a significant regulatory milestone towards approval of bimekizumab in Europe. We’re delighted by today’s decision which recognizes the strength of the psoriasis clinical development program. Bimekizumab is testament to our commitment to advancing science in immuno-dermatology, addressing unmet needs and improving patient outcomes,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

The positive CHMP opinion is supported by results from three Phase 3 studies – BE VIVID, BE READY and BE SURE – which evaluated the efficacy and safety of bimekizumab in adults with moderate to severe plaque psoriasis.[i]^,[ii]^,[iii] All studies met their co-primary and all ranked secondary endpoints.^i,ii,iii Patients treated with bimekizumab achieved superior levels of skin clearance (PASI 90 and IGA 0/1**) at week 16 compared to those who received adalimumab, placebo and ustekinumab.^i,ii,iii Clinical responses achieved with bimekizumab at week 16 were maintained up to one year in all studies.^i,ii,iii The most frequently reported treatment emergent adverse events in bimekizumab-treated patients were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.^i,ii,iii,[iv]

If marketing authorization is granted by the European Commission, bimekizumab will become the first approved treatment for patients with moderate to severe plaque psoriasis in the European Union that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.^i,ii,iii The positive CHMP opinion is a scientific recommendation which is shared with the European Commission for the adoption of a decision on an EU-wide marketing authorization. A European Commission marketing authorization through the centralized procedure is valid in all European Union Member States, as well as the European Economic Area countries Iceland, Liechtenstein and Norway.

UCB is committed to bringing bimekizumab to patients worldwide. Bimekizumab is currently under review by the U.S. Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis. Regulatory reviews are also underway in Japan, Australia and Canada. The efficacy and safety of bimekizumab are also being evaluated in Phase 3 trials in psoriatic arthritis,[v]^,[vi] ankylosing spondylitis,[vii] non-radiographic axial spondyloarthritis,[viii] and hidradenitis suppurativa.[ix]^,[x]

Notes to Editors:                                                                                                                                                                                                               

* The proprietary name BIMZELX^® has been provisionally accepted by the EMA                                                                                                                 

** PASI 90 - at least a 90 percent improvement in the Psoriasis Area and Severity Index; IGA 0/1 - Investigator’s Global Assessment response of clear or almost clear skin.

About Psoriasis

Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.[xi] This skin condition affects men and women of all ages and ethnicities.^xi 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.[xii] Psoriasis also has a considerable psychological and quality-of-life impact, potentially affecting work, recreation, relationships, sexual functioning, family and social life.[xiii]

Unmet needs remain in the treatment of psoriasis. A population-based survey identified that approximately one in three 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.[xiv]

 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 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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For further information, UCB:

[i]   Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.

[ii]   Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.

[iii] Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis.  N Engl J Med. 2021;10.1056/NEJMoa2102388.

^[iv]  UCB Data on File. June 2021.

[v] 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: June 2021.

[vi] 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: June 2021.

[vii] 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: June 2021.

[viii] 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: June 2021.

[ix] 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: June 2021.

[x] 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: June 2021.

[xi] National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/. Last accessed: June 2021.

^[xii] International Federation of Psoriasis Associations. Available at: www.ifpa-pso.com/our-cause//. Last accessed: June 2021.

^[xiii] Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130.

^[xiv] 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.