Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 21 |
| INN | Brodalumab |
| Status | Approved |
| Drug code(s) | AMG 827, KHK4827 |
| Brand name | Siliq, Lumicef |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Xenomouse) |
| Target(s) | IL-17RA |
| Indications of clinical studies | Systemic Sclerosis, Palmoplantar Pustulosis, Rheumatoid Arthritis, Psoriatic Arthritis, Asthma, Psoriasis, Crohn's Disease |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2007 |
| Start of Phase 2 | December 15, 2009 |
| Start of Phase 3 | August 15, 2012 |
| Date BLA/NDA submitted to FDA | November 16, 2015 |
| Year of first approval (global) | 2016 |
| Date of first US approval | February 15, 2017 |
| INN, US product name | Brodalumab |
| US or EU approved indications | Psoriasis (treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond, or have stopped responding to other systemic therapies) |
| Company | Amgen |
| Licensee/Partner | Kyowa Hakko Kirin, AstraZeneca, Valeant, LEO Pharma |
| Comments about company or candidate | Approved in Japan on July 4, 2016 for psoriasis; Approved in US on Feb 15, 2017: Approved in EU on July 17, 2017 U.S. Food and Drug Administration (FDA) has voted by a margin of 18 to 0 for the approval of brodalumab injection, 210 mg, for adult patients with moderate-to-severe plaque psoriasis with conditions related to product labeling and post-marketing/risk management obligations. AZ sold LEO the rights to psoriasis drug brodalumab after ending an earlier deal with Valeant Pharmaceuticals; Valeant licensed brodalumab in Aug 2015; Under the agreement, Valeant will hold the exclusive rights to develop and commercialize brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co. Amgen dropped collaboration to develop brodalumab after suicidal thoughts were observed in patients; Phase III trial to treat psoriatic arthritis halted |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |