Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 41 |
| INN | Alemtuzumab |
| Status | Approved |
| Drug code(s) | CAMPATH-1H, LDP-03 |
| Brand name | Lemtrada, Campath |
| 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) | CD52 |
| Indications of clinical studies | Multiple sclerosis, chronic lymphocytic leukemia |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 15, 1988 |
| Start of Phase 2 | September 15, 1992 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | December 23, 1999 |
| Year of first approval (global) | 2001 |
| Date of first US approval | May 07, 2001 |
| INN, US product name | Alemtuzumab |
| US or EU approved indications | Multiple sclerosis (treatment of patients with relapsing forms of multiple sclerosis) |
| Company | Millennium Pharmaceuticals Inc. |
| Licensee/Partner | None |
| Comments about company or candidate | First approved in 2001 for chronic myeloid leukemia; withdrawn for this indication and then approved in 2013 (EU) and 2014 (US) for multiple sclerosis |
| Full address of company | PO Box 616, Castle Hill, NSW 2154 Australia Australia https://www.milleniumpharma.com.au/contact |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |