Entry ID | 3 |
INN | Abciximab |
Status | Approved |
Drug code(s) | 7E 3 |
Brand name | Reopro |
mAb sequence source | mAb chimeric |
General Molecular Category | Naked monospecific |
Format, general category | Fragment |
Format details | Fab |
Isotype (Fc) | None |
Light chain isotype | kappa |
Linker | None |
Ave. DAR | None |
Conjugated/fused moiety | None |
Discovery method/technology | None |
Target(s) | GP IIb/IIIa receptor |
Indications of clinical studies | Prevention of blood clots |
Primary therapeutic area | Cardiovascular / hemostasis disorders |
Most advanced stage of development (global) | Approved EU, US |
Status | Active |
Start of clinical phase (IND filing or first Phase 1) | July 02, 1987 |
Start of Phase 2 | November 15, 1989 |
Start of Phase 3 | November 26, 1991 |
Date BLA/NDA submitted to FDA | December 16, 1993 |
Year of first approval (global) | 1994 |
Date of first US approval | December 22, 1994 |
INN, US product name | Abciximab |
US or EU approved indications | Acute Coronary Syndrome, Percutaneous Coronary Interventions for Stable Angina |
Company | Centocor |
Licensee/Partner | Tanabe Seiyaku |
Comments about company or candidate | None |
Full address of company | 800-850 Ridgeview Drive HORSHAM PA 19044 UNITED STATES North America United States of America https://www.orpha.net/en/institutions/legal-entity/82182 |
None
Anticipated events | None |
Factor(s) contributing to discontinuation | None |