Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 90 |
| INN | Benralizumab |
| Status | Approved |
| Drug code(s) | KHK4563, BIW-8405, MEDI-563 |
| Brand name | FASENRA |
| 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-5R alpha |
| Indications of clinical studies | Atopic dermatitis, Eosinophilic Esophagitis, Asthma, Chronic Obstructive Pulmonary Disease |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2006 |
| Start of Phase 2 | |
| Start of Phase 3 | September 01, 2013 |
| Date BLA/NDA submitted to FDA | November 16, 2016 |
| Year of first approval (global) | 2017 |
| Date of first US approval | November 14, 2017 |
| INN, US product name | Benralizumab |
| US or EU approved indications | Asthma (add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype); intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (US approval on April 26, 2019) |
| Company | Kyowa Hakko Kirin |
| Licensee/Partner | AstraZeneca |
| Comments about company or candidate | Aug 2024: AstraZeneca’s Fasenra (benralizumab) has been approved in China by the country’s National Medical Products Association (NMPA) for the maintenance treatment of patients 12 years of age and older with severe eosinophilic asthma. Approved in US November 14, 2017; approved in EU Jan 10, 2018 Two Phase 3 studies in asthma started in Sep 2013 |
| Full address of company | Tokyo, Japan Asia Japan https://www.kyowakirin.com/index.html |
Low/no fucose (POTELLIGENT technology)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |