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- The FDA designated the BLA resubmission as ‘Class 2’ with a six-month review period
- The FDA action is expected in Q2 2023
Brussels/Atlanta, December 23, 2022 – 07:00 ET – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) resubmission for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. The FDA designated the resubmission as ‘Class 2’ with a six-month review period. The FDA action is expected in the second quarter of 2023.
“The FDA acceptance of our resubmitted application for bimekizumab is positive news that moves us one step closer to providing the first dual IL-17A and IL-17F inhibitor to address the unmet needs of people with moderate to severe plaque psoriasis in the U.S. We will continue to work with the FDA through the review process with the goal of bringing bimekizumab to the dermatology community in the U.S. as soon as possible,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
In November 2022, UCB announced resubmission of the BLA for bimekizumab, for the treatment of adults with moderate to severe plaque psoriasis, following receipt of a complete response letter in May 2022.
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 the U.S., the efficacy and safety of bimekizumab have not been established for any indication and it is not approved by the U.S. Food and Drug Administration (FDA).
In August 2021, bimekizumab was approved in the European Union (EU)/European Economic Area (EEA) and in 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 and March 2022, bimekizumab received marketing authorization in Canada and Australia respectively, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.5,6 In July and October 2022, bimekizumab received marketing authorization in Saudi Arabia and Switzerland respectively, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.7,8
For further information, contact UCB:
U.S. Immunology Communications
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 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
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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.
Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.
- 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 Summary of Product Characteristics, December 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last Accessed: December 2022.
- BIMZELX® (bimekizumab) GB Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/12834/smpc#gref Last Accessed: December 2022.
- Pharmaceuticals and Medical Devices Agency. New Drugs Approved in FY 2021. https://www.pmda.go.jp/files/000246734.pdf. Last Accessed: December 2022.
- BIMZELX® (bimekizumab) Canada Product Monograph. Available at: https://pdf.hres.ca/dpd_pm/00064702.PDF Last Accessed: December 2022.
- Therapeutics Drug Administration Available at: https://www.tga.gov.au/resources/auspmd/bimzelx Last Accessed: December 2022
- Saudi Food & Drug Authority https://www.sfda.gov.sa/en Last Accessed: December 2022.
- Swissmedic Available at: https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/authorisations/new-medicines/bimzelx-injlsg-fertigspritze-bimekizumabum.html Last Accessed: December 2022.
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