Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 143 |
| INN | Mepolizumab |
| Status | Approved |
| Drug code(s) | SB-240563 |
| Brand name | Nucala |
| 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-5 |
| Indications of clinical studies | Atopic dermatitis, Chronic obstructive pulmonary disease, Hypereosinophilic Syndrome, Asthma, Eosinophilic Oesophagitis, Eosinophilic Granulomatosis with Polyangiitis (aka Churg Strauss Syndrome), Nasal Polyps |
| 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) | July 02, 1996 |
| Start of Phase 2 | October 15, 1997 |
| Start of Phase 3 | October 15, 2003 |
| Date BLA/NDA submitted to FDA | November 04, 2014 |
| Year of first approval (global) | 2015 |
| Date of first US approval | November 04, 2015 |
| INN, US product name | Mepolizumab |
| US or EU approved indications | Asthma, Eosinophilic granulomatosis with polyangiitis; treatment of pediatric patients with severe eosinophilic asthma between the ages of 6 to 11; FDA's approval in 2015 was for supplementary maintenance therapy for patients with severe asthma aged 12 years or older. |
| Company | GlaxoSmithKline |
| Licensee/Partner | PDL |
| Comments about company or candidate | Approved in US Nov 4, 2015 and in the EU in early Dec 2015 |
| Full address of company | 980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |