Entry ID | 46 |
INN | Reslizumab |
Status | Approved |
Drug code(s) | CEP-38072, CDP-835, SCH-55700 |
Brand name | Cinquil |
mAb sequence source | mAb humanized |
General Molecular Category | Naked monospecific |
Format, general category | Full length Ab |
Format details | None |
Isotype (Fc) | IgG4 |
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 | Eosinophilic Asthma, Eosinophilic Esophagitis |
Primary therapeutic area | Immune-mediated / inflammatory disorders |
Most advanced stage of development (global) | Approved EU, US, Australia |
Status | Active |
Start of clinical phase (IND filing or first Phase 1) | July 02, 1997 |
Start of Phase 2 | |
Start of Phase 3 | February 15, 2008 |
Date BLA/NDA submitted to FDA | March 30, 2015 |
Year of first approval (global) | 2016 |
Date of first US approval | March 23, 2016 |
INN, US product name | Reslizumab |
US or EU approved indications | Astham (Add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype) |
Company | UCB |
Licensee/Partner | Teva, Schering-Plough |
Comments about company or candidate | Positive Phase III Results for Reslizumab Reducing Asthma Exacerbations released in Sep 2014 Partner Teva acquired Cephalon in 2011; Cephalon acquired Ception in 2009. |
Full address of company | Allée de la Recherche, 60 1070 Brussels Belgium Europe Belgium https://www.ucb.com/contact |
Wild-type hinge
Anticipated events | None |
Factor(s) contributing to discontinuation | None |