UCB Provides Update on U.S. Regulatory Review of Bimekizumab
Brussels (Belgium), 19 September 2023 – Time (23:00 CEST) – Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today provided an update on the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.
UCB has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) following the pre-license inspection conducted in April 2023 at the Belgium manufacturing facility. The FDA has concluded that this inspection is successfully closed.
The FDA is continuing its review of the BLA for bimekizumab. The Agency has not communicated timelines required to take action on the application. At this time, UCB no longer anticipates FDA action in Q3, 2023.
UCB continues to collaborate with the FDA to advance and complete the full review of the bimekizumab BLA and its label. The next update for the bimekizumab BLA will be shared at the time of the FDA action.
UCB’s previously communicated 2023 financial guidance range remains unchanged.
Notes to editors:
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 first 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 first 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:
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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- 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.
- BIMZELX (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf Accessed: September 2023.
- BIMZELX (bimekizumab) GB SmPC. https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833 Accessed: September 2023.
- Pharmaceuticals and Medical Devices Agency. https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html. Accessed: September 2023.
- BIMZELX (bimekizumab) Canada Product Monograph. Available at: https://pdf.hres.ca/dpd_pm/00064702.PDF. Accessed: September 2023.
- BIMZELX. Australian Prescription Medicine Decision Summaries. Available at: https://www.tga.gov.au/apm-summary/bimzelx. Accessed: September2023.
- Saudi Food & Drug Authority. https://www.sfda.gov.sa/sites/default/files/2023-04/Bimzelx.pdf. Last accessed: September 2023.
- 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: September 2023.
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