Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 107 |
| INN | Vedolizumab |
| Status | Approved |
| Drug code(s) | MLN02, LDP-02 |
| Brand name | Entyvio |
| 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) | Integrin alpha-4 beta-7 |
| Indications of clinical studies | Colitis, Crohn's Disease |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 1998 |
| Start of Phase 2 | |
| Start of Phase 3 | December 15, 2008 |
| Date BLA/NDA submitted to FDA | June 20, 2013 |
| Year of first approval (global) | 2014 |
| Date of first US approval | May 20, 2014 |
| INN, US product name | Vedolizumab |
| US or EU approved indications | Ulcerative colitis, Crohn's Disease |
| Company | Millennium Pharmaceuticals Inc. |
| Licensee/Partner | Genentech |
| Comments about company or candidate | CHMP positive opinion given March 20, 2014; EU approval anticipated ~June 1. As per March 7, 2013 press release, Takeda submitted an MAA for ulcerative colitis and Crohn disease. BLA submitted in June 2013 and recd priority review status; approved May 20, 2014 for ulcerative colitis and Crohn's disease |
| Full address of company | PO Box 616, Castle Hill, NSW 2154 Australia Australia https://www.milleniumpharma.com.au/contact |
Blocks binding of α4β7to MAdCAM-1; does not bind to α4β1or αEβ7; Mutated Fc region (L235A, G237) to silence effector functions - does not elicit complement-mediated cytotoxicity, ADCC, cytokine release
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |