Drugs / Brodalumab
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed ankylosing spondylitis 1 milestone | |||||
| Filed | Japan (PMDA) | LUMICEF | ankylosing spondylitis | 2020-01-08 | “announces today that it has submitted a supplemental application for LUMICEF® (code name: KHK4827, generic name: brodalumab (genetic mutation))” kyowakirin.com ↗ |
| Filed pustular psoriasis 1 milestone | |||||
| Filed | Japan (PMDA) | — | pustular psoriasis | 2015-07-30 | “announced today that it has filed an application for marketing approval to the Ministry of Health, Labour and Welfare for Brodalumab (code name: KHK4827)” kyowakirin.com ↗ |
| Filed systemic sclerosis 1 milestone | |||||
| Filed | Japan (PMDA) | LUMICEF | systemic sclerosis | 2021-12-15 | “the company has filed an application to the Japanese Ministry of Health, Labour and Welfare for partial change of approved indication of LUMICEF® [KHK4827, generic name:...” kyowakirin.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Kyntheum | — | 2017-07-17 | europa.eu ↗ |
| Approved | US (FDA) | SILIQ | — | 2017-02-15 | fda.gov ↗ |
Trials 45
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04979520 | Aug 2021 → Jul 2022 | hidradenitis suppurativa | Rockefeller University | Completed | No outcome recorded |
| Phase 0 | NCT04249713 | Feb → Jul 2020 | hidradenitis suppurativa | Rockefeller University | Withdrawn | No outcome recorded |
| Phase 0 | NCT03960268 | May 2019 → Jun 2020 | hidradenitis suppurativa | Rockefeller University | Completed | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT06673329 | Mar 2025 → May 2027 expected | brain neoplasm, breast cancer, colon carcinoma, esophageal cancer +13 | Brian Henick, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT04368403 | Oct 2017 → Jan 2019 | systemic sclerosis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01937260 | Sep 2013 → Jul 2014 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01488201 | Nov 2011 → Sep 2012 | psoriasis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01395485 | Jun 2011 → Jun 2012 | asthma | Amgen | Withdrawn | No outcome recorded |
| Phase 1 | NCT00867100 | Dec 2007 → Sep 2009 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00771030 | Oct 2008 → May 2010 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 211 trials · 1 met primary · 4 missed | ||||||
| Phase 2 | NCT03910803 | May → Dec 2019 | hidradenitis suppurativa | Florida Academic Dermatology Centers | Unknown | No outcome recorded |
| Phase 2 | NCT01902290 | May 2013 → May 2015 | asthma | Amgen | Terminated | Missed primary |
| Phase 2 | NCT01748539 | Dec 2012 → Sep 2013 | psoriasis | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 2 | NCT01516957 | Oct 2011 → Sep 2012 | psoriatic arthritis | Bausch Health Americas, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01199302 | Feb → Oct 2011 | Crohn disease | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT01150890 | Nov 2010 → Oct 2011 | Crohn disease | Amgen | Terminated | Missed primary |
| Phase 2 | NCT01199289 | Oct 2010 → Dec 2011 | asthma | Amgen | Completed | Missed primary |
| Phase 2 | NCT01059448 | Jun 2010 → Apr 2011 | rheumatoid arthritis | Amgen | Terminated | No outcome recorded |
| Phase 2 | NCT01101100 | Apr 2010 → Sep 2015 | psoriasis | Bausch Health Americas, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00950989 | Dec 2009 → Feb 2011 | rheumatoid arthritis | Amgen | Completed | Missed primary |
| Phase 2 | NCT00975637 | Dec 2009 → Jul 2010 | psoriasis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 314 trials · 5 met primary | ||||||
| Phase 3 | NCT04305327 | Dec 2022 → May 2023 | psoriasis | LEO Pharma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04061252 | Aug 2019 → Aug 2021 | palmoplantar pustulosis | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 3 | NCT03957681 | May 2019 → Oct 2020 | systemic sclerosis | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 3 | NCT02985983 | Mar 2017 → Sep 2019 | spondyloarthropathy | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 3 | NCT02982005 | Jan 2017 → Aug 2018 | psoriasis | Kyowa Kirin Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02024646 | Mar 2014 → Oct 2015 | psoriatic arthritis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02029495 | Mar 2014 → Oct 2015 | psoriatic arthritis | Bausch Health Americas, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02052609 | Feb 2014 → Jan 2015 | palmoplantar pustulosis, psoriatic arthritis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01782924 | Mar 2013 → Feb 2015 | psoriasis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01782937 | Feb 2013 → Dec 2014 | psoriasis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01708629 | Sep 2012 → Aug 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01708590 | Aug 2012 → May 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | Met primary Stop: Business |
| Phase 3 | NCT02786732 | Aug 2012 → Jun 2017 | psoriasis | MedDerm Associates | Terminated | No outcome recorded |
| Phase 3 | NCT01708603 | Aug 2012 → Sep 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | Met primary Stop: Business |
| Phase 410 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04306315 | Jul 2022 → Aug 2025 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 4 | NCT04614298 | Jan 2021 → Feb 2022 | psoriasis | Kyowa Kirin, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04533737 | Dec 2020 → Sep 2022 | psoriasis | LEO Pharma | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT04622033 | Dec 2020 → Nov 2021 | psoriasis | First OC Dermatology | Unknown | No outcome recorded |
| Phase 4 | NCT04340076 | Aug 2020 → Jan 2025 | psoriasis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03240809 | Jan 2020 → Dec 2028 expected | psoriasis | Bausch Health Americas, Inc. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03331835 | Nov 2017 → Jan 2019 | psoriasis | LEO Pharma | Completed | Met primary |
| Phase 4 | NCT03403036 | Oct 2017 → Aug 2018 | psoriasis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT04183881 | Jul 2016 → Jan 2017 | palmoplantar pustulosis, psoriatic arthritis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT02429882 Comparator | May 2015 | spondyloarthropathy | Amgen | Withdrawn | No outcome recorded |
| Phase 4 | NCT03478280 Comparator | Sep 2018 → Mar 2020 | psoriasis | Aarhus University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2023-08-23 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Received Partial Change Approval of LUMICEF® for Palmoplantar Pustulosis in Japan kyowakirin.com ↗
LUMICEF® is the first IL-17 pathway inhibitor approved in PPP. |
| 2022-09-15 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces Application for Partial Change of Approved Indication of LUMICEF® for Palmoplantar Pustulosis in Japan kyowakirin.com ↗
Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) announced that the company has filed an application to the Japanese Ministry of Health, Labour and Welfare for partial change of approved indication of LUMICEF®*1 [KHK4827, generic name: brodalumab (genetical recombination)] for palmoplantar pustulosis (PPP) *2 in Japan on September 15th. |
| 2022-09-07 | Kyowa Kirin, Inc. | Results Kyowa Kirin Presents Positive Data from Phase 3 Study of LUMICEF® in Palmoplantar Pustulosis at EADV 2022 Congress kyowakirin.com ↗
Brodalumab also demonstrated the trend toward improvement in many of the secondary efficacy endpoints compared to placebo. |
| 2022-06-01 | Kyowa Kirin, Inc. | Results Kyowa Kirin Presents Positive Data from Phase 3 Study of LUMICEF® in Systemic Sclerosis at EULAR 2022 Congress kyowakirin.com ↗
Brodalumab showed a statistically significant improvement in the primary endpoint, change from the baseline in mRSS*3 at week 24, compared to placebo (-21.2 [95% CI: -23.9, 18.5]; P<0.0001), thus the efficacy of brodalumab was confirmed. |
| 2021-12-15 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces Application for Partial Change of Approved Indication of LUMICEF® for Systemic Sclerosis in Japan kyowakirin.com ↗
Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) announced that the company has filed an application to the Japanese Ministry of Health, Labour and Welfare for partial change of approved indication of LUMICEF® [KHK4827, generic name: brodalumab (genetical recombination)] for systemic sclerosis in Japan on December 15th. |
| 2020-11-27 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces Partial Change Approval of LUMICEF® for the Treatment of Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis in Japan kyowakirin.com ↗
Kyowa Kirin Co., Ltd. (TSE: 4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") announces today that LUMICEF® (code name: KHK4827, generic name: brodalumab (genetic mutation)) was granted the supplemental approval for the treatment of ankylosing spondylitis (AS)*1 and non-radiographic axial spondyloarthritis (nr-axSpA)*2 in Japan. |
| 2020-01-08 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Submitted Partial Change Approval Application of LUMICEF® in Japan kyowakirin.com ↗ |
| 2019-06-17 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Top-Line Results of Phase 3 Study of Brodalumab (KHK4827) in Patients with Axial Spondyloarthritis and Oral Presentation at EULAR kyowakirin.com ↗
Moreover, the percentages of AS subjects (N=125) and nr-axSpA subjects (N=33) who achieved ASAS40 also tended to be higher in the brodalumab group than in the placebo group, as in the axSpA subjects. |
| 2017-07-20 | AstraZeneca | Regulatory Kyntheum approved in the EU for the treatment of adults with moderate-to-severe plaque psoriasis astrazeneca.com ↗ |
| 2017-05-19 | AstraZeneca | Regulatory Brodalumab receives positive CHMP opinion for the treatment of adult patients with moderate-to-severe plaque psoriasis astrazeneca.com ↗
The CHMP’s positive opinion on brodalumab will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). |
| 2017-02-16 | AstraZeneca | Regulatory Siliq (brodalumab) approved by the US FDA for adult patients with moderate-to-severe plaque psoriasis astrazeneca.com ↗ |
| 2016-07-04 | Kyowa Kirin, Inc. | Regulatory LUMICEF® approved in Japan kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that LUMICEF® Subcutaneous Injection 210 mg Syringe (code name: KHK4827, generic name: Brodalumab (Genetical Recombination), hereafter LUMICEF®) has been approved in Japan, the first approval of the product worldwide. |
| 2015-09-30 | AstraZeneca | Results New England Journal of Medicine publishes results of head-to-head studies of brodalumab versus ustekinumab in psoriasis astrazeneca.com ↗
Publication of these data in NEJM underscores the importance of brodalumab as a potential new treatment for people with psoriasis, a serious, chronic disease that can have an overwhelming, negative impact on patients’ lives. |
| 2015-07-30 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Submits Application for Approval in Japan for Brodalumab (KHK4827) kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed an application for marketing approval to the Ministry of Health, Labour and Welfare for Brodalumab (code name: KHK4827) which is developed for plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. |
| 2015-07-23 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Results of the Phase 3 Studies of KHK4827 in Subjects with Psoriasis in Japan kyowakirin.com ↗
At week 52, Psoriasis Area and Severity Index* (PASI) had improved in 91.1% of patients treated with 140mg and 94.0% of patients treated with 210mg, confirming that long-term effects were maintained. |
| 2014-11-25 | AstraZeneca | Results Amgen and AstraZeneca announce positive results from third and final pivotal Phase III study of Brodalumab in patients with moderate-to-severe plaque psoriasis astrazeneca.com ↗
Brodalumab 210 mg given every two weeks and the brodalumab weight-based analysis group were each shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100). |
| 2014-11-25 | Amgen | Results Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis amgen.com ↗
When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75 percent improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75). |
| 2014-11-18 | AstraZeneca | Results AstraZeneca strategy on track to deliver sustainable growth and value through innovation astrazeneca.com ↗
Brodalumab, being developed in partnership with Amgen, showed superiority to Stelara (ustekinumab) in achieving total skin clearance (PASI 100) and met co-primary end-points against placebo. |
| 2014-11-11 | AstraZeneca | Results Amgen and AstraZeneca announce positive results from second pivotal Phase III study of Brodalumab in patients with moderate-to-severe plaque psoriasis astrazeneca.com ↗
AstraZeneca and Amgen today announced that AMAGINE-3TM, a pivotal, multi-arm Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. |
| 2014-06-11 | AstraZeneca | Results Brodalumab treatment improved clinical signs and symptoms in Phase II psoriatic arthritis study published in the New England Journal of Medicine astrazeneca.com ↗
The study also showed that many patients continued to improve, and that the improvements were sustained, through the first 52 weeks of the study reported in NEJM. |
| 2014-05-15 | AstraZeneca | Results Continuing progress in accelerating late stage pipeline reinforces confidence in AstraZeneca’s strategy as an independent company astrazeneca.com ↗
In collaboration with Amgen, Phase III study of brodalumab (AMG 827) in patients with moderate-to-severe plaque psoriasis met its primary and secondary endpoints. |
| 2014-05-09 | AstraZeneca | Results Amgen and AstraZeneca announce positive results from Phase III study of brodalumab (AMG 827) in patients with moderate-to-severe plaque psoriasis astrazeneca.com ↗
AstraZeneca and Amgen today announced that the Phase III AMAGINE-1TM study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis met all primary and secondary endpoints for both evaluated doses. |
| 2013-10-31 | Kyowa Kirin, Inc. | Results Results of a Phase 2 Study of KHK4827 in Subjects with Psoriasis in Japan kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced today that KHK4827 (Generic name: brodalumab) achieved the primary efficacy endpoint in a phase 2 study to treat subjects with plaque psoriasis in Japan. |
All press releases naming this drug 31 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Brodalumab | “Brodalumab (KHK4827 or AMG 827) is a human monoclonal antibody that binds to the human interleukin (IL)-17 receptor A and blocks the biological activities of IL-17A, IL-17F,...” PMID 26547109 ↗ Oct 201534“Brodalumab is a fully human anti-interleukin-17 receptor A monoclonal antibody efficacious for the treatment of adults with moderate-to-severe plaque psoriasis.” PMID 32207067 ↗ Jun 2020 “Brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, is being investigated for use in PPP treatment.” PMID 38954226 ↗ Jul 2024 “A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis” NCT04614298 ↗ “KHK4827 (brodalumab)” NCT02982005 ↗ “Brodalumab (Lumicef)” NCT07149792 ↗ |
| Known as | AMG 827 | “Brodalumab (KHK4827 or AMG 827) is a human monoclonal antibody that binds to the human interleukin (IL)-17 receptor A and blocks the biological activities of IL-17A, IL-17F,...” PMID 26547109 ↗ Oct 20157“Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827” NCT00867100 ↗ “Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate” NCT00950989 ↗ |
| Known as | KHK4827 | “A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis” NCT04614298 ↗ |
| Known as | Kyntheum | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742996 ↗ |
| Known as | Lumicef | “Brodalumab (Lumicef)” NCT07149792 ↗ |
| Known as | Siliq | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742996 ↗ |
| Action | Inhibit | “Brodalumab treatment resulted in inhibition of IL-17 receptor signaling” PMID 24286136 ↗ Oct 2013 |
| Modality | Monoclonal antibody | “a human, anti-IL-17 receptor A (IL-17RA) monoclonal antibody” PMID 24286136 ↗ Oct 2013 |
| Route | Intravenous | “brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group)” PMID 24286136 ↗ Oct 2013 |
| Route | Subcutaneous | “brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group)” PMID 24286136 ↗ Oct 2013 |
| Target | IL17RA | “anti-IL17RA monoclonal antibody” PMID 33827787 ↗ Apr 2021 |