BIMZELX[®] (bimekizumab) approved in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma

This announcement marks the third approval for bimekizumab worldwide, following marketing authorization in countries of the European Union/European Economic Area and Great Britain in August 2021 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. (1,2)

“The approval of BIMZELX® in Japan is an important milestone that reinforces UCB’s commitment to the dermatology community and to advancing standards of care in psoriasis,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB. “At UCB, our ambition is to transform the lives of people living with severe diseases. We are incredibly proud to bring a new psoriasis treatment option to healthcare professionals and patients in Japan to help support more patients in reaching their treatment goals.”

Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin. (3) There are several types of psoriasis, though plaque psoriasis is the most common, comprising between 58 percent and 97 percent of all cases. (4) Plaque psoriasis is characterized by dry, red plaques, usually covered with silvery or white scales. (4) Generalized pustular psoriasis is less common, affecting between 1.1 percent and 12 percent of all cases, and characterized by coalescing pustules, filled with non-infectious pus. (4) Psoriatic erythroderma is the most serious type of psoriasis characterized by fiery redness and exfoliation of most of the body surface, affecting between 0.4 percent and 7 percent of all cases. (4)

The approval in Japan is supported by the positive results from the Phase 3/3b clinical studies, BE READY, BE VIVID, BE SURE and BE RADIANT which evaluated the efficacy and safety of bimekizumab compared with placebo, ustekinumab, adalimumab and secukinumab in adults with moderate to severe plaque psoriasis, as well as results from the open-label extension study BE BRIGHT. (5,6,7,8,9) Bimekizumab demonstrated superior levels of skin clearance* compared to placebo, ustekinumab, adalimumab and secukinumab, and was generally well-tolerated. (5,6,7,8,9) Full findings from the BE READY and BE VIVID studies are published in The Lancet, and the results from the BE SURE and BE RADIANT studies are published in The New England Journal of Medicine. (5,6,7,8)

UCB is committed to bringing bimekizumab to patients worldwide. Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults. Regulatory reviews are also underway in Australia, Canada and Switzerland.

*Bimekizumab was evaluated in Phase 3/3b studies versus placebo (co-primary endpoint; BE READY and BE VIVID), versus adalimumab (co-primary endpoint; BE SURE), versus ustekinumab (ranked secondary endpoint; BE VIVID) and versus secukinumab (primary endpoint; BE RADIANT). (5,6,7,8)

About BIMZELX® (bimekizumab)

Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively and directly inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes. (10)

About BIMZELX® ▼ in the EU/EEA*

In the EU, BIMZELX® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. (1)

*EU/EEA means European Union/European Economic Area

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 €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB).

References

(1) BIMZELX® (bimekizumab) EU Summary of Product Characteristics https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: January 2022.

(2) 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: January 2022.

(3) National Psoriasis Foundation. About Psoriasis webpage. Available at: https://www.psoriasis.org/about-psoriasis/. Last accessed: January 2022.

(4) World Health Organization. Global report on psoriasis 2016. Available at: http://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf;jsessionid=8753AFAF296B0371998310C3AB7F3259?sequence=1. Last accessed: January 2022.

(5) 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.

(6) 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.

(7) Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.

(8) Reich K, Warren R, Lebwohl M et al. Bimekizumab versus Secukinumab in Plaque Psoriasis N Engl J Med. 2021;385(2):142-152.

(9) ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE BRIGHT). Available at: https://clinicaltrials.gov/ct2/show/NCT03598790?term=NCT03598790&draw=2&rank=1. Last accessed: January 2022.

(10) 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.