Drugs / Bimekizumab
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hidradenitis suppurativa 3 milestones | |||||
| Filed | US (FDA) | BIMZELX | hidradenitis suppurativa | 2024-04-04 | “In April 2024, UCB also announced that the U.S. Food and Drug Administration accepted for review the supplemental biologics license application for bimekizumab-bkzx for the...” ucb.com ↗ |
| Filed | EU (EMA) | — | hidradenitis suppurativa | 2023-07-18 | “the European Medicines Agency (EMA) has accepted for review the marketing authorization application of bimekizumab” ucb.com ↗ “has accepted for review the marketing authorization application for bimekizumab” ucb.com ↗ |
| Filed | Japan (PMDA) | — | hidradenitis suppurativa | — | “In November 2023 , UCB filed bimekizumab for the treatment of hidradenitis suppurativa (HS), a chronic, painful, and debilitating skin condition, with PMDA in Japan.” ucb.com ↗ |
| Filed juvenile ankylosing spondylitis 1 milestone | |||||
| Filed | US (FDA) | BIMZELX | juvenile ankylosing spondylitis | 2024-02-28 | “U.S. FDA accepted the filings of BIMZELX ® for psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS).” ucb.com ↗ authority ucb.com ↗ |
| Filed psoriasis 3 milestones | |||||
| Filed | US (FDA) | — | psoriasis | 2022-11-22 | “today announced that it has resubmitted the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bimekizumab for the treatment of adults with...” ucb.com ↗ “UCB announced that the FDA and EMA had accepted the Company’s Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab” ucb.com ↗ “In September 2020, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted marketing application submissions for bimekizumab” ucb.com ↗ “resubmitted the BLA to the FDA for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis” ucb.com ↗ |
| Rejected (CRL) | US (FDA) | — | psoriasis | — | “FDA 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.com ↗ “Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis.” ucb.com ↗ “The resubmission follows the receipt of a Complete Response Letter (CRL) from the FDA in May 2022” ucb.com ↗ |
| Filed | EU (EMA) | — | psoriasis | — | “UCB announced that the FDA and EMA had accepted the Company’s Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab” ucb.com ↗ “In September 2020, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted marketing application submissions for bimekizumab” ucb.com ↗ |
| Filed psoriatic arthritis 2 milestones | |||||
| Filed | US (FDA) | BIMZELX | psoriatic arthritis | 2024-02-28 | “U.S. FDA accepted the filings of BIMZELX ® for psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS).” ucb.com ↗ |
| Filed | EU (EMA) | — | psoriatic arthritis | 2022-09-20 | “In September 2022, UCB announced that the European Medicines Agency had accepted the marketing authorization application for bimekizumab for the treatment of active psoriatic...” ucb.com ↗ “EMA accepted for regulatory review the two marketing authorization applications (MAA) for bimekizumab for the treatment of adult patients with active psoriatic arthritis (PsA)” ucb.com ↗ “accepted for regulatory review the two marketing authorization applications for bimekizumab for the treatment of adult patients with active psoriatic arthritis (PsA)” ucb.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Bimzelx | — | 2021-08-20 | europa.eu ↗ |
Trials 52
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 1 met primary | ||||||
| Phase 1 | NCT07290036 | Dec 2025 → May 2028 expected | psoriatic arthritis, spondyloarthropathy | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 1 | NCT06888193 | Nov 2025 → Dec 2027 expected | hidradenitis suppurativa, psoriasis, psoriatic arthritis, spondyloarthropathy | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 1 | NCT03895385 | Apr → Oct 2019 | — | UCB Biopharma S.P.R.L. | Completed | No outcome recorded |
| Phase 1 | NCT03707717 | Oct 2018 → Jun 2019 | — | UCB Biopharma S.P.R.L. | Completed | No outcome recorded |
| Phase 1 | NCT05028127 | Mar → Jun 2016 | — | UCB Celltech | Completed | No outcome recorded |
| Phase 1 | NCT02141763 | May 2014 → Aug 2015 | psoriatic arthritis | UCB Celltech | Completed | Met primary |
| Phase 1 | NCT02529956 | Nov 2012 → Jan 2014 | psoriasis | UCB Celltech | Completed | No outcome recorded |
| Phase 214 trials · 5 met primary · 1 missed | ||||||
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06742333 | Jul 2025 → Jul 2028 expected | psoriasis | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 2 | NCT04718896 | Apr 2021 → Mar 2025 | psoriasis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 2 | NCT03355573 | Nov 2017 → Oct 2022 | ankylosing spondylitis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 2 | NCT03347110 | Nov 2017 → Oct 2020 | psoriatic arthritis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 2 | NCT03215277 | Oct 2017 → May 2020 | ankylosing spondylitis | UCB Biopharma SRL | Completed | Missed primary |
| Phase 2 | NCT03248531 | Sep 2017 → Nov 2018 | hidradenitis suppurativa | UCB Biopharma SRL | Completed | Met primary |
| Phase 2 | NCT03230292 | Jul 2017 → Mar 2019 | psoriasis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 2 | NCT03025542 | Dec 2016 → Dec 2017 | psoriasis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 2 | NCT03010527 | Dec 2016 → Sep 2018 | psoriasis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 2 | NCT02963506 | Oct 2016 → Oct 2017 | ankylosing spondylitis | UCB Biopharma S.P.R.L. | Completed | Met primary |
| Phase 2 | NCT02969525 | Oct 2016 → Nov 2017 | psoriatic arthritis | UCB Biopharma S.P.R.L. | Completed | Met primary |
| Phase 2 | NCT02905006 | Aug 2016 → Jun 2017 | psoriasis | UCB Biopharma S.P.R.L. | Completed | Met primary |
| Phase 2 | NCT02430909 | Apr 2015 → Apr 2017 | rheumatoid arthritis | UCB Celltech | Completed | Met primary |
| Phase 324 trials · 13 met primary | ||||||
| Phase 3 | NCT07836283 | Oct 2026 → Apr 2030 expected | spondyloarthropathy | University Hospital, Rouen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07219420 | Nov 2025 → Dec 2027 expected | palmoplantar pustulosis | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 3 | NCT06921850 | Apr 2025 → Dec 2026 expected | hidradenitis suppurativa | UCB Biopharma SRL | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06668181 | Mar 2025 → Apr 2028 expected | enthesitis-related juvenile idiopathic arthritis, psoriasis-related juvenile idiopathic arthritis | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 3 | NCT06624228 | Oct 2024 → Feb 2026 | psoriatic arthritis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT06506916 | Jul 2024 → Mar 2027 expected | psoriasis, psoriatic arthritis | UCB Biopharma SRL | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06425549 | Jun 2024 → Aug 2028 expected | psoriasis | UCB Biopharma SRL | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06011733 | Oct 2023 → Feb 2025 | psoriasis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT05020249 | Sep 2021 → Sep 2022 | psoriasis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT04901195 | May 2021 → Jul 2026 | hidradenitis suppurativa | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT04436640 | Jun 2020 → Aug 2026 | ankylosing spondylitis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT04242498 | Mar 2020 → Nov 2021 | hidradenitis suppurativa | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT04242446 | Feb 2020 → Apr 2022 | hidradenitis suppurativa | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT04009499 | Aug 2019 → May 2026 | psoriatic arthritis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT03928743 | Apr 2019 → Sep 2021 | ankylosing spondylitis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT03928704 | Apr 2019 → Jun 2022 | spondyloarthropathy | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT03895203 | Apr 2019 → Aug 2021 | psoriatic arthritis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT03896581 | Mar 2019 → Dec 2021 | psoriatic arthritis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT03766685 | Dec 2018 → Jul 2020 | psoriasis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT03598790 | Sep 2018 → Nov 2023 | psoriasis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT03536884 | Jun 2018 → Sep 2019 | psoriasis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT03410992 | Feb → Dec 2018 | psoriasis, psoriatic arthritis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT03412747 | Jan 2018 → Feb 2019 | psoriasis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT03370133 | Dec 2017 → Jan 2019 | psoriasis, psoriatic arthritis | UCB Biopharma SRL | Completed | Met primary |
| Phase 47 trials | ||||||
| Phase 4 | NCT07497620 | Oct 2026 → Oct 2027 expected | pityriasis rubra pilaris | Mayo Clinic | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07554014 | Apr 2026 → Sep 2027 expected | hidradenitis suppurativa | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06336343 | Jun 2024 → Mar 2026 | psoriasis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT05499416 | Jan → Sep 2023 | psoriasis, psoriatic arthritis | Innovaderm Research Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04340076 | Aug 2020 → Jan 2025 | psoriasis | Radboud University Medical Center | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT04109976 Background | Aug 2019 → Nov 2020 | psoriatic arthritis | UCB Biopharma SRL | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 69
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | UCB Pharma | Results UCB announces new data at EADV 2026 supporting earlier use of BIMZELX[®] (bimekizumab) for treating hidradenitis suppurativa ucb.com ↗
At three years, 47.4% of patients with the shortest duration since diagnosis achieved IHS4‑100 vs 33.3% of those with the longest duration since diagnosis |
| 2026-06-03 | UCB Pharma | Results BIMZELX[®](bimekizumab) data at EULAR 2026 show early and sustained inflammation control can improve patient reported outcomes and limit disease progression in PsA and axSpA ucb.com ↗ |
| 2026-05-19 | UCB Pharma | Results BIMZELX[®](bimekizumab) demonstrates superior efficacy over SKYRIZI[®] (risankizumab) in psoriatic arthritis: BE BOLD Week 16 data ucb.com ↗
UCB, a global biopharmaceutical company, today announced Week 16 data from the BE BOLD trial demonstrating superior ACR50 joint outcomes at Week 16 for BIMZELX ® (bimekizumab) versus SKYRIZI®(risankizumab) in adults living with active psoriatic arthritis (PsA). |
| 2026-03-27 | UCB Pharma | Results UCB presents new BIMZELX[®] (bimekizumab-bkzx) data at AAD demonstrating high rates of durable and complete skin clearance in moderate-to-severe plaque psoriasis ucb.com ↗
62.6% and 64.9% of those receiving bimekizumab-bkzx achieved NPF-defined on-treatment remission for at least six months in the first year of BE RADIANT and BE VIVID, respectively* |
| 2026-03-27 | UCB Pharma | Results UCB announces new BIMZELX[®] (bimekizumab-bkzx) data at AAD showing durable symptom control throughout three years in hidradenitis suppurativa ucb.com ↗
86.1% of people living with moderate to severe hidradenitis suppurativa (HS) treated with bimekizumab-bkzx had no acute exacerbation of symptoms, known as ‘flares’, to three years in a post hoc analysis* |
| 2026-03-11 | UCB Pharma | Results BIMZELX[®]▼(bimekizumab) superior to SKYRIZI[®] (risankizumab) in BE BOLD: first head-to-head study in active psoriatic arthritis (PsA) to demonstrate superiority in ACR50 ucb.com ↗
Bimekizumab achieved statistically significant superiority over risankizumab in reducing disease activity, as measured by the stringent ACR50 endpoint, at Week 16 in adults living with active psoriatic arthritis |
| 2026-02-04 | UCB Pharma | Results UCB showcases three-year hidradenitis suppurativa data at EHSF: BIMZELX[®]▼(bimekizumab) achieved inflammatory lesion resolution and substantial disease severity improvements ucb.com ↗
Bimekizumab, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL 17F), 1 demonstrated total resolution of inflammatory lesions and substantial improvements in disease severity, sustained to three years. |
| 2025-10-31 | UCB Pharma | Results BIMZELX[®] (bimekizumab-bkzx) data in hidradenitis suppurativa showed improvements in pain and resolution of draining tunnels sustained to three years ucb.com ↗
UCB, a global biopharmaceutical company, today announced three-year data from the BE HEARD trials^ for BIMZELX[®] (bimekizumab-bkzx) in moderate to severe hidradenitis suppurativa (HS). |
| 2025-10-25 | UCB Pharma | Results BIMZELX[®] (bimekizumab-bkzx) three year rheumatology data at ACR 2025 demonstrated sustained inflammation control in psoriatic arthritis and axial spondyloarthritis ucb.com ↗
From Week 16 to three years, 50% of patients never lost ASDAS low disease activity (LDA) (<2.1) status at any assessed visit – indicating sustained inflammation control |
| 2025-09-17 | UCB Pharma | Results BIMZELX[®]▼(bimekizumab) new three-year data in hidradenitis suppurativa at EADV showed sustained disease control across the most stringent clinical endpoints ucb.com ↗
UCB, a global biopharmaceutical company, today announced three-year data from the BE HEARD trials^ for BIMZELX ® (bimekizumab) in moderate to severe hidradenitis suppurativa (HS). |
| 2025-09-17 | UCB Pharma | Results BIMZELX[®][▼] (bimekizumab) data in moderate-to-severe plaque psoriasis at EADV showed four-year sustained remission, and potential to reduce psoriatic arthritis progression risk ucb.com ↗
UCB, a global biopharmaceutical company, today announced three- and four-year data from across their Phase 3 trials for BIMZELX ® (bimekizumab) in moderate-to-severe plaque psoriasis. |
| 2025-07-08 | UCB Pharma | Results BIMZELX[®][ ](bimekizumab-bkzx) two-year data at AAD showed potential to eliminate draining tunnels in hidradenitis suppurativa (HS), and reduction in disease burden ucb.com ↗
Over half of patients had no draining tunnels (DTs) at two years: In 425 HS patients with ≥1 DTs at baseline, 55.7% (195/350) had no DTs at two years of treatment. |
| 2025-06-11 | UCB Pharma | Results BIMZELX[®]▼(bimekizumab) three-year data at EULAR 2025 showed lasting efficacy and control of inflammation in psoriatic arthritis and axial spondyloarthritis ucb.com ↗
UCB, a global biopharmaceutical company, today announced new three-year data from Phase 3 trials, and their open-label extensions, investigating BIMZELX ® ▼(bimekizumab) in adults with active psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). |
| 2025-03-07 | UCB Pharma | Results BIMZELX[®] (bimekizumab-bkzx) two-year data at AAD showed potential to eliminate draining tunnels in hidradenitis suppurativa (HS), and reduction in disease burden ucb.com ↗
In 425 HS patients with ≥1 DTs at baseline, 55.7% (195/350) had no DTs at two years of treatment. |
| 2025-03-07 | UCB Pharma | Results BIMZELX[®] (bimekizumab-bkzx) five-year data at AAD 2025 showed sustained skin clearance and long-term efficacy in moderate-to-severe plaque psoriasis ucb.com ↗
In a subset of 153 patients from the second extension of BE BRIGHT, 67.7% of patients with moderate-to-severe plaque psoriasis (PSO) treated with BIMZELX ® (bimekizumab-bkzx) achieved PASI100 + at five years |
| 2025-02-12 | UCB Pharma | Results BIMZELX[®]▼(bimekizumab) two-year data at EHSF 2025 demonstrate sustained disease control in hidradenitis suppurativa (HS) ucb.com ↗
UCB, a global biopharmaceutical company, today announced long-term data from the BE HEARD^ trials for BIMZELX ® ▼ (bimekizumab) in moderate to severe hidradenitis suppurativa (HS). |
| 2024-11-20 | UCB Pharma | Regulatory UCB receives U.S. FDA approval for BIMZELX[®] (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX ® (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). |
| 2024-11-14 | UCB Pharma | Results New BIMZELX[®] (bimekizumab-bkzx) data at ACR Convergence 2024 highlights UCB’s efforts to deliver differentiated care for patients with psoriatic arthritis and axial spondyloarthritis ucb.com ↗
New two-year data demonstrated sustained improvements in clinical and patient-reported outcomes in PsA, nr-axSpA and AS patients treated with bimekizumab-bkzx |
| 2024-10-14 | UCB Pharma | Regulatory UCB receives U.S. FDA approval for 320 mg single-injection device presentations of BIMZELX[®] (bimekizumab-bkzx) ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of BIMZELX ® (bimekizumab-bkzx). |
| 2024-09-27 | UCB Pharma | Results UCB announces late-breaking two-year data for BIMZELX[®]▼(bimekizumab) in moderate to severe hidradenitis suppurativa at EADV 2024 ucb.com ↗
Results showed that the clinically meaningful improvements observed with bimekizumab treatment at one year were maintained over two years. |
| 2024-09-25 | UCB Pharma | Results UCB presents new 4-year data for BIMZELX[®]▼(bimekizumab) in moderate to severe plaque psoriasis at EADV 2024 ucb.com ↗
UCB, a global biopharmaceutical company, today announced the presentation of new four-year data in patients with moderate to severe plaque psoriasis treated with bimekizumab, an IL-17A and IL-17F inhibitor. |
| 2024-09-23 | UCB Pharma | Regulatory UCB announces U.S. FDA approvals for BIMZELX[®] (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis ucb.com ↗ |
| 2024-08-05 | UCB Pharma | Regulatory UCB announces European Commission approval for 320 mg device presentations of BIMZELX[®]▼(bimekizumab) ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the European Commission (EC) has granted marketing authorization for two 320 mg device presentations of BIMZELX® (bimekizumab). |
| 2024-06-12 | UCB Pharma | Results UCB to share first presentations of BIMZELX[®]▼ (bimekizumab) two-year data in axial spondyloarthritis and psoriatic arthritis at EULAR 2024 ucb.com ↗
Patients with non-radiographic axial spondyloarthritis (nr-axSpA) and those with radiographic axSpA (r-axSpA) treated with bimekizumab showed sustained and consistent clinical and patient-reported outcomes up to two years |
| 2024-05-31 | UCB Pharma | Regulatory UCB announces positive CHMP opinion for 320 mg device presentations of BIMZELX[®]▼ (bimekizumab) ucb.com ↗ |
| 2024-05-23 | UCB Pharma | Results UCB announces publication in The Lancet of phase 3 bimekizumab▼ trials in moderate to severe hidradenitis suppurativa ucb.com ↗
In these studies, bimekizumab consistently demonstrated sustained improvements in clinical- as well as patient-reported outcomes for people with moderate to severe disease. |
| 2024-04-22 | UCB Pharma | Regulatory UCB receives European Commission approval for BIMZELX[®]▼(bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe hidradenitis suppurativa ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the European Commission (EC) has granted marketing authorization for BIMZELX ® (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. |
| 2024-04-04 | UCB Pharma | Regulatory FDA Accepts Supplemental Biologics License Applications for BIMZELX[®] (bimekizumab-bkzx) for Moderate to Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations ucb.com ↗
In addition, a second sBLA for the bimekizumab-bkzx 2mL device presentations has also been accepted. |
| 2024-03-22 | UCB Pharma | Regulatory UCB receives positive CHMP opinion for BIMZELX[®]▼(bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for BIMZELX ® (bimekizumab) in the European Union (EU)/European Economic Area (EEA) for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy. |
| 2024-03-09 | UCB Pharma | Results First presentation of four-year BIMZELX[®](bimekizumab-bkzx) data showed long-term maintenance of complete skin clearance in moderate to severe plaque psoriasis ucb.com ↗
Late-breaking platform presentation showed that bimekizumab-bkzx rapidly achieved and maintained high rates of clinical and health-related quality-of-life responses through four years; six out of ten patients achieved complete skin clearance at Year 4 |
| 2024-03-08 | UCB Pharma | Results Bimekizumab 48-week Phase 3 analyses in moderate to severe hidradenitis suppurativa showed sustained improvements in skin pain and draining tunnel count ucb.com ↗
Analyses showed that bimekizumab-treated patients reported clinically meaningful improvements in skin pain up to 48 weeks across various assessed outcomes, including the HS Symptom Questionnaire (HSSQ) skin pain item, the Patient Global Impression of Severity of Skin Pain (PGI-S-SP) and the Change in Severity of Skin Pain (PGI-C-SP). |
| 2024-02-09 | UCB Pharma | Results Latest analyses of bimekizumab phase 3 studies in moderate to severe hidradenitis suppurativa to be presented at EHSF 2024 ucb.com ↗
Bimekizumab treatment demonstrated improvements in overall lesion count and lesion clearance, across abscesses, inflammatory nodules and draining tunnels over 48 weeks |
| 2023-12-27 | UCB Pharma | Regulatory BIMZELX® (bimekizumab) Receives Approval in Japan for the Treatment of Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis and Ankylosing Spondylitis ucb.com ↗
Bimekizumab is the first IL-17A and IL-17F inhibitor to receive regulatory approval in Japan for the treatment of psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) in adult patients |
| 2023-11-10 | UCB Pharma | Results UCB Presents New Five-Year Data on BIMZELX[®]▼(bimekizumab) in Ankylosing Spondylitis at ACR Convergence 2023 ucb.com ↗ |
| 2023-10-18 | UCB Pharma | Regulatory BIMZELX[®] Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis ucb.com ↗
UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved BIMZELX ® (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. |
| 2023-10-12 | UCB Pharma | Results Phase 3 Data Analysis Presented at EADV 2023 Showed Bimekizumab Achieved High Thresholds of Clinical Response in Hidradenitis Suppurativa ucb.com ↗
Bimekizumab treatment resulted in clinically meaningful improvements in HiSCR50 and the more stringent endpoints HiSCR75, HiSCR90 and HiSCR100 vs. placebo at Week 16, with improvements increasing for patients remaining in the study through Week 48 |
| 2023-10-09 | UCB Pharma | Results UCB to Present New Bimekizumab Data in Hidradenitis Suppurativa, Psoriasis and Psoriatic Arthritis at EADV 2023 ucb.com ↗
Bimekizumab improves key patient reported symptoms of axial spondyloarthritis including spinal pain and fatigue: Results from two phase 3 studies |
| 2023-09-19 | UCB Pharma | Regulatory UCB Provides Update on U.S. Regulatory Review of Bimekizumab ucb.com ↗
The FDA has concluded that this inspection is successfully closed. |
| 2023-07-18 | UCB Pharma | Regulatory UCB Announces EU Regulatory Filing for Bimekizumab for the Treatment of Moderate to Severe Hidradenitis Suppurativa ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the European Medicines Agency (EMA) 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 (HS). |
| 2023-06-07 | UCB Pharma | Regulatory UCB Receives New European Commission Approvals for BIMZELX[®]▼(bimekizumab) for the Treatment of Psoriatic Arthritis and Axial Spondyloarthritis ucb.com ↗
Bimekizumab is the first and only IL-17A and IL-17F inhibitor approved in the European Union for active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA) |
| 2023-05-31 | UCB Pharma | Results New Long-Term Data on Bimekizumab in Psoriatic Arthritis and Axial Spondyloarthritis Presented at EULAR 2023 ucb.com ↗
These results from the bimekizumab phase 3 program in PsA and axSpA are being presented at the European Congress of Rheumatology, EULAR 2023, in Milan, Italy, May 31–June 3. |
| 2023-04-27 | UCB Pharma | Regulatory UCB Receives Positive CHMP Opinions for Bimekizumab for the Treatment of Adults with Psoriatic Arthritis and Axial Spondyloarthritis in the European Union ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions recommending granting marketing authorization for bimekizumab in the European Union (EU) for the treatment of adults with active axial spondyloarthritis (axSpA) and for adults with active psoriatic arthritis (PsA). |
| 2023-03-18 | UCB Pharma | Results Bimekizumab Phase 3 Data in Hidradenitis Suppurativa Show Clinically Meaningful, Deep and Maintained Response over 48 Weeks ucb.com ↗
Data from the two studies showed that bimekizumab achieved statistically significant and consistent clinically meaningful improvements over placebo in the signs and symptoms of HS at week 16, which were maintained to week 48. |
| 2023-01-18 | UCB Pharma | Results Annals of the Rheumatic Diseases Publishes Results from Two Bimekizumab Phase 3 Studies in Axial Spondyloarthritis ucb.com ↗
The two phase 3 studies, BE MOBILE 1 and BE MOBILE 2, met all primary and ranked secondary endpoints at Week 16. |
| 2022-12-23 | UCB Pharma | Regulatory UCB Announces FDA Acceptance of BLA Resubmission for Bimekizumab ucb.com ↗ |
| 2022-12-09 | UCB Pharma | Results UCB Announces Positive Phase 3 Studies for Bimekizumab in Hidradenitis Suppurativa ucb.com ↗
UCB, a global biopharmaceutical company, today announced positive top-line results from two Phase 3 studies, BE HEARD I and BE HEARD II, evaluating the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa. |
| 2022-12-07 | UCB Pharma | Results The Lancet Publishes Results from Two Bimekizumab Phase 3 Studies in Psoriatic Arthritis ucb.com ↗
Data from BE OPTIMAL and BE COMPLETE show that both studies met their primary and all ranked secondary endpoints. |
| 2022-11-22 | UCB Pharma | Regulatory UCB Submits Response to FDA Complete Response Letter for Bimekizumab ucb.com ↗
UCB, a global biopharmaceutical company, today announced that it has resubmitted the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. |
| 2022-11-10 | UCB Pharma | Results Bimekizumab Demonstrated Sustained Clinical Responses to Week 52 in Phase 3 Studies in Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis ucb.com ↗
At week 52, 54.5 percent of patients continuously treated with bimekizumab, 53.0 percent of patients who switched from placebo to bimekizumab at week 16, and 50.0 percent of patients in the reference arm (adalimumab) achieved ACR50. |
| 2022-09-20 | UCB Pharma | Regulatory European Medicine Agency Accepts Marketing Authorization Applications for Bimekizumab in Psoriatic Arthritis and Axial Spondyloarthritis ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the European Medicines Agency (EMA) has accepted for regulatory review the two marketing authorization applications for bimekizumab for the treatment of adult patients with active psoriatic arthritis (PsA), and adult patients with active axial spondyloarthritis (axSpA). |
| 2022-09-07 | UCB Pharma | Results New Three-Year BIMZELX[®]▼ (bimekizumab) Data Reinforce Long-Term Maintenance of Complete Skin Clearance in Moderate to Severe Plaque Psoriasis ucb.com ↗
Over eight out of 10 patients who achieved complete skin clearance (PASI 100) at week 16 maintained PASI 100 responses and health-related quality of life outcomes through to three years |
| 2022-05-23 | UCB Pharma | Results UCB Announces First Detailed Data from Two Phase 3 Bimekizumab Studies in Psoriatic Arthritis to be Presented at EULAR 2022 ucb.com ↗
UCB, a global pharmaceutical company, today announced detailed results from two Phase 3 studies which evaluated the efficacy and safety of bimekizumab versus placebo in the treatment of adults with active psoriatic arthritis who were biologic disease-modifying anti-rheumatic drug naïve (BE OPTIMAL) and in adults who had an inadequate response or intolerance to tumour necrosis factor inhibitors (BE COMPLETE). |
| 2022-05-23 | UCB Pharma | Results First Presentations of Phase 3 Data for Bimekizumab Across the Full Spectrum of Axial Spondyloarthritis to be Shared at EULAR 2022 ucb.com ↗
UCB, a global pharmaceutical company, today announced new 24-week data from two Phase 3 studies, BE MOBILE 1 and BE MOBILE 2, evaluating bimekizumab in the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) and active ankylosing spondylitis (AS). |
| 2022-05-13 | UCB Pharma | Regulatory Update on U.S. FDA Review of Biologics License Application (BLA) for bimekizumab ucb.com ↗ |
| 2022-03-26 | UCB Pharma | Results New Long-Term Complete Skin Clearance Data for BIMZELX[®]▼ (bimekizumab) in Moderate to Severe Plaque Psoriasis Presented at the 2022 AAD Annual Meeting ucb.com ↗
Pooled data from five Phase 3/3b trials showed that more than eight out of 10 patients who achieved complete skin clearance with bimekizumab at week 16, and entered open-label extension, maintained this response through two years |
| 2022-01-24 | UCB Pharma | Regulatory BIMZELX[®] (bimekizumab) Approved in Japan for the Treatment of Plaque Psoriasis, Generalized Pustular Psoriasis and Psoriatic Erythroderma ucb.com ↗ |
| 2022-01-21 | UCB Pharma | Results Positive Top-Line Results for BIMZELX[®]▼(bimekizumab) in Second Phase 3 Psoriatic Arthritis Study ucb.com ↗
The study also met all ranked secondary endpoints. |
| 2022-01-18 | UCB Pharma | Results Positive Top-Line Results for BIMZELX[®]▼(bimekizumab) in Phase 3 Non-Radiographic Axial Spondyloarthritis Study ucb.com ↗
UCB, a global biopharmaceutical company, today announced positive top-line interim analysis results showing that the Phase 3 BE MOBILE 1 study met the primary and all ranked secondary endpoints. |
| 2021-12-16 | UCB Pharma | Results Positive Top-Line Results for BIMZELX[®]▼(bimekizumab) in Phase 3 Ankylosing Spondylitis Trial ucb.com ↗
The BE MOBILE 2 study met its primary endpoint, as measured by the proportion of patients who achieved the Assessment of SpondyloArthritis International Society 40 (ASAS40) response at week 16, when compared to placebo. |
| 2021-11-19 | UCB Pharma | Results Positive Top-Line Results from BIMZELX®▼(bimekizumab) Phase 3 Psoriatic Arthritis Study Demonstrated Significant Improvements in Joint and Skin Symptoms ucb.com ↗
The BE OPTIMAL study met the primary endpoint and all ranked secondary endpoints with statistical significance |
| 2021-10-16 | UCB Pharma | Regulatory Update on U.S. FDA Review of Biologics License Application (BLA) for bimekizumab ucb.com ↗ |
| 2021-09-29 | UCB Pharma | Results New BIMZELX[®]▼ (bimekizumab) two-year data in moderate to severe plaque psoriasis presented at the 30th European Academy of Dermatology and Venereology (EADV) Congress ucb.com ↗
Interim results from the BE BRIGHT open-label extension study showed clinical responses observed in bimekizumab-treated patients during the first 16 weeks of BE SURE were sustained through to two years of treatment with continuous maintenance dosing* |
| 2021-08-24 | UCB Pharma | Regulatory UCB Announces European Commission Approval of BIMZELX[®]▼ (bimekizumab) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the European Commission (EC) has granted marketing authorization for BIMZELX ® (bimekizumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. |
| 2021-08-07 | UCB Pharma | Results New Two-Year Data Showed Bimekizumab Maintained High Levels of Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis ucb.com ↗
Data presented showed that the majority of patients who achieved complete or near complete skin clearance after 16 weeks of bimekizumab treatment maintained these responses through to two years with continuous maintenance dosing, every four weeks (Q4W) or every eight weeks (Q8W). |
| 2021-06-25 | UCB Pharma | Regulatory UCB Receives Positive CHMP Opinion Recommending Approval of BIMZELX[®*] (bimekizumab) in the EU for the Treatment of Adults with Moderate to Severe Plaque Psoriasis ucb.com ↗
This positive CHMP opinion is a significant regulatory milestone towards approval of bimekizumab in Europe. |
| 2021-06-01 | UCB Pharma | Results EULAR 2021: New Data from UCB’s Rheumatology Portfolio Demonstrates Real World Value for Patients with axSpA, PsA, and Women of Childbearing Age ucb.com ↗
Long-term safety, efficacy and patient-reported outcomes and quality of life data on UCB’s investigational IL-17A and IL-17F inhibitor, bimekizumab, show its potential to make a meaningful difference for people living with ankylosing spondylitis (AS) and PsA |
| 2021-04-28 | UCB Pharma | Regulatory UCB Announces PDUFA Date for Bimekizumab ucb.com ↗
UCB announced today that the U.S. Food and Drug Administration (FDA) has set the Prescription Drug User Fee Act (PDUFA) date for UCB’s Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis at October 15, 2021. |
| 2021-04-23 | UCB Pharma | Results The New England Journal of Medicine Publishes Results from Two Bimekizumab Phase 3 Studies in Moderate to Severe Plaque Psoriasis ucb.com ↗
In BE RADIANT, bimekizumab was superior to secukinumab in achieving complete skin clearance (PASI 100) at week 16, the primary endpoint of the study, and at week 48, a ranked secondary endpoint |
| 2021-02-05 | UCB Pharma | Results The Lancet Publishes Two Phase 3 Studies Detailing Bimekizumab Data in Moderate to Severe Plaque Psoriasis ucb.com ↗ |
All press releases naming this drug 74 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bimekizumab | “bimekizumab, a humanised monoclonal IgG1 antibody” PMID 29275332 ↗ Dec 201752“Bimekizumab 120 mg + NAFL (1565 nm)” NCT07554014 ↗ “bimekizumab (formerly UCB4940)” PMID 27859546 ↗ Jan 2017 “Bimekizumab (Bimzelx)” NCT07149792 ↗ |
| Known as | Bimekizumab-bkzx | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297700 ↗ |
| Known as | Bimzelx | “Bimekizumab (Bimzelx)” NCT07149792 ↗ |
| Known as | BKZ | “Bimekizumab (BKZ), an IL-17A and IL-17F inhibitor, has demonstrated a rapid and high level of complete skin clearance in patients with psoriasis and complete normalization of...” PMID 41580158 ↗ Jan 20262“OBJECTIVE: To assess the long-term safety profile of bimekizumab (BKZ) in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).” PMID 40194794 ↗ Apr 2025 “Participants will receive bimekizumab (BKZ) at pre-specified time points.” NCT07290036 ↗ |
| Known as | BZK | “Evaluation of the Efficacy and Safety of Bimekizumab (BZK) or Adalimumab (ADA) in the Treatment of Anterior Chest Wall Pain Associated With Active Axial Spondyloarthritis...” NCT07836283 ↗ |
| Known as | UCB4940 | “The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with...” NCT02430909 ↗ |
| Action | Inhibit | “Neutralisation of IL-17A and IL-17F with bimekizumab” PMID 29275332 ↗ Dec 2017 |
| Modality | Monoclonal antibody | “bimekizumab, a humanised monoclonal IgG1 antibody” PMID 29275332 ↗ Dec 2017 |
| Route | Intravenous | “Route of Administration: intravenous” NCT02141763 ↗ |
| Target | IL17A | “a monoclonal antibody that selectively neutralises IL17A and IL17F” PMID 32035552 ↗ Feb 2020 |
| Target | IL17F | “a monoclonal antibody that selectively neutralises IL17A and IL17F” PMID 32035552 ↗ Feb 2020 |