Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 157 |
| INN | Bimekizumab |
| Status | Approved |
| Drug code(s) | UCB4940, 496.g3 |
| Brand name | Bimzelx |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-17A, IL-17F |
| Indications of clinical studies | Hidradenitis Suppurativa, Psoriasis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, Canada, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 01, 2011 |
| Start of Phase 2 | October 15, 2012 |
| Start of Phase 3 | December 06, 2017 |
| Date BLA/NDA submitted to FDA | July 15, 2020 |
| Year of first approval (global) | 2021 |
| Date of first US approval | October 18, 2023 |
| INN, US product name | Bimekizumab, bimekizumab-bkzx |
| US or EU approved indications | US: treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy EU: treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy; treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA. |
| Company | UCB |
| Licensee/Partner | None |
| Comments about company or candidate | Oct 18, 2023:FDA approval announced July 18, 2023: UCB announced that the European Medicines Agency has accepted for review the marketing authorization application for bimekizumab, an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa. 23 December 2022: UCB 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. In August 2021, bimekizumab (BIMZELX) 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. 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. 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. 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. May 13, 2022 – UCB announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. UCB aims to submit the response to the bimekizumab CRL to the U.S. FDA by the end of 2022. (https://www.ucb.com/sites/default/files/2022-07/UCB_Half-Year_2022_Report_EN.pdf) October 16, 2021 – UCB announced that the U.S. Food and Drug Administration (FDA) has informed the Company that they were unable to complete review of the Biologics License Application (BLA) for bimekizumab for the treatment of moderate to severe plaque psoriasis by the Prescription Drug User Fee Action (PDUFA) date of October 15, 2021. The Agency has determined that on-site inspections of the European manufacturing facilities for bimekizumab are required before the FDA can approve the application. The FDA indicated that they were unable to conduct the inspections during the current review cycle due to COVID-19 related restrictions on travel. Therefore, the FDA is deferring action on the application until the inspections can be completed. In the letter, the Agency cited only travel restrictions and its inability to complete facility inspections as the reason for the deferral. The BLA for bimekizumab remains under review. 24th August 2021 UCB announced that the European Commission has granted marketing authorization for BIMZELX® (bimekizumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. In an earnings call on July 27, 2020, UCB announced that, earlier in July 2020, the company submitted regulatory applications to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for regulatory approval of bimekizumab for the treatment of psoriasis. Approved by EC on August 20, 2021. Complete Response The original BLA for bimekizumab (BLA 761151) was submitted on July 15, 2020. NCT04436640 Phase 3 study not yet recruiting when first posted on June 18, 2020. NCT03928743 Phase 3 study in AS and NCT03928704 Phase 3 study in Nonradiographic Axial Spondyloarthritis started recruiting on April 25, 2019. March 2, 2019: UCB, a global biopharmaceutical company, presented positive data from the Phase 2b BE ABLE extension study of bimekizumab in patients with moderate-to-severe chronic plaque psoriasis, which showed nearly all BE ABLE 1 responders completing 60 weeks of bimekizumab treatment maintained complete or almost complete skin clearance. Oct 2018: UCB presented long-term data for the first time from BE ACTIVE studying bimekizumab in psoriatic arthritis (PsA) patients. The results were presented as part of a late-breaking oral session at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting. The abstract was entitled "Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with Active Psa: Results from a 48-Week Phase 2b, Randomized, Double‑Blind, Placebo-Controlled, Dose-Ranging Study". Four Phase 3 studies in psoriasis and AS recruiting as of July 2018. Data were presented in an abstract entitled "Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients With Active Ankylosing Spondylitis: 12-Week Results From a Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Study" presented at the Annual European Congress of Rheumatology (EULAR) on June 13, 2018. The primary and key secondary objectives were achieved; dual neutralisation of IL-17A and IL-17F with bimekizumab provided clinically meaningful improvements in disease outcome measures. No new safety signals were observed versus previous studies. Total of 8 Phase 2 studies listed on clinicaltrials.gov as of Aug 7, 2017, 4 are recruiting or not yet recruiting. Phase 2 listed on EU clinical trials register with EudraCT number 2012-002086-35; specifically noted as not the first in humans study. NCT02141763 Phase 1 study in psoriatic arthritis started in May 2014 |
| Full address of company | Allée de la Recherche, 60 1070 Brussels Belgium Europe Belgium https://www.ucb.com/contact |
Epitope is common to both IL-17A and IL-17F. Among IL-17 family members, IL-17F is closest in sequence to IL-17A, sharing ~50% structural homology. Description of bimekizumab: We identified 496.g1, a humanized antibody with strong affinity for IL-17A but poor affinity for IL-17F. Affinity maturation of 496.g1 to 496.g3 greatly enhanced the affinity of the Fab fragment for IL-17F while retaining strong binding to IL-17A. As an IgG1, the affinity for IL-17A and IL-17F was 3.2 pM and 23 pM, respectively. Comparison of 496.g3 IgG1 with the commercially available anti-IL-17A monoclonal antibodies ixekizumab and secukinumab, by surface plasmon resonance and in a human in vitro IL-17A functional assay, showed that 496.g3 and ixekizumab display equivalent affinity for IL-17A, and that both antibodies are markedly more potent than secukinumab. In contrast to ixekizumab and secukinumab, 496.g3 exhibited the unique feature of also being able to neutralize the biological activity of IL-17F. Therefore, antibody 496.g3 was selected for clinical development for its ability to neutralize the biologic function of both IL-17A and IL-17F and was renamed bimekizumab (formerly UCB4940). (Adams et al. doi: 10.3389/fimmu.2020.01894)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |