UCB Provides Update on U.S. FDA Review of the Biologics License Application for Bimekizumab

Brussels (Belgium), 26th June 2023 – 18:30 CEST – Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced that the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis remains under review with the U.S. Food & Drug Administration (FDA). UCB previously communicated the FDA action was expected in Q2, 2023. UCB now anticipates the FDA action in Q3, 2023. There are no open Information Requests from the FDA regarding the BLA for bimekizumab.

UCB is committed to ongoing collaboration with the FDA in order to bring bimekizumab to people in the U.S. living with moderate to severe plaque psoriasis as soon as possible. 

Bimekizumab, an IL-17A and IL-17F inhibitor, is currently approved for moderate to severe psoriasis by 10 regulatory authorities and in 39 countries worldwide.^1-8 In June 2023, in countries of the European Union/European Economic Area, bimekizumab was approved for two additional indications – the treatment of adults with active psoriatic arthritis, and for the treatment of adults with active axial spondyloarthritis (axSpA), including non-radiographic axSpA and ankylosing spondylitis, also known as radiographic axSpA.²

UCB confirms its previously communicated 2023 financial guidance range.

UCB will host a UCB Investor Call on 27th June: 15:15–15:45 CEST; 09:15 am –09:45 am EST; 14:15–14:45 BST. Participant International Dial In: +1-412-902-6510; Participant UK/EU Dial In: +44 203 5143188.

Notes to editors:

About bimekizumab

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.¹ In August 2021, bimekizumab▼received marketing authorization in countries of the European Union (EU)/European Economic Area (EEA) and Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.^2,3 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.⁴ In February 2022, March 2022 and April 2023, bimekizumab received marketing authorization in Canada, Australia and Mexico, respectively, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.^5,6 In July 2022, October 2022, January 2023 and May 2023 bimekizumab was approved in Saudi Arabia⁷, Switzerland⁸, the United Arab Emirates and Kuwait, respectively, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 

In June 2023, bimekizumab was approved in countries of the EU/EEA, alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.² In June 2023, bimekizumab was approved in countries of the EU/EEA, for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs, and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.² 

▼ 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 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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References

1. 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.
2. BIMZELX (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf  Accessed: June 2023.
3. BIMZELX (bimekizumab) GB SmPC. https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833 Accessed: June 2023.
4. Pharmaceuticals and Medical Devices Agency. https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html. Accessed: June 2023.
5. BIMZELX (bimekizumab) Canada Product Monograph. Available at: https://pdf.hres.ca/dpd_pm/00064702.PDF. Accessed: June 2023.
6. BIMZELX. Australian Prescription Medicine Decision Summaries. Available at: https://www.tga.gov.au/apm-summary/bimzelx. Accessed: June 2023.
7. Saudi Food & Drug Authority. https://www.sfda.gov.sa/sites/default/files/2023-04/Bimzelx.pdf. Last accessed: June 2023.
8. Swissmedic. Available at: https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/public-summary-swiss-par/public-summary-swiss-par-bimzelx.html.  Last accessed: June 2023.