Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 44 |
| INN | Certolizumab pegol |
| Status | Approved |
| Drug code(s) | CDP-870 |
| Brand name | Cimzia |
| mAb sequence source | mAb humanized |
| General Molecular Category | Immunoconjugate, Pegylated |
| Format, general category | Fragment conjugate |
| Format details | Fab, pegylated |
| Isotype (Fc) | None |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | PEG |
| Discovery method/technology | None |
| Target(s) | TNF |
| Indications of clinical studies | Rheumatoid arthritis, 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) | July 02, 1998 |
| Start of Phase 2 | September 15, 1998 |
| Start of Phase 3 | October 15, 2002 |
| Date BLA/NDA submitted to FDA | March 01, 2006 |
| Year of first approval (global) | 2008 |
| Date of first US approval | April 22, 2008 |
| INN, US product name | Certolizumab pegol |
| US or EU approved indications | Reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy; Treatment of adults with moderately to severely active rheumatoid arthritis; Treatment of adult patients with active psoriatic arthritis; Treatment of adults with active ankylosing spondylitis; Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Treatment of non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. |
| Company | UCB |
| Licensee/Partner | None |
| Comments about company or candidate | May 2004: UCB Group, the Belgian specialty chemical and pharmaceutical conglomerate, will acquire British biopharmaceutical company Celltech Group for $2.7 billion. UCB obtains exclusive worldwide rights to develop and commercialize Celltech's lead drug candidate, CDP870, which is currently in Phase III clinical trials for arthritis and Crohn's disease. (https://cen.acs.org/articles/82/i21/UCB-SET-BUY-UK-BIOTECH.html). Curr Opin Investig Drugs. 2003 May;4(5):588-92: Celltech Group plc (formerly Celltech Chiroscience), in collaboration with Pfizer Inc (formerly Pharmacia Corp), is developing CDP-870, a polyethylene glycol (PEG)ylated anti-TNF antibody fragment, for the potential treatment of certain autoimmune and inflammatory diseases, including rheumatoid arthritis (RA) and Crohn's disease (CD). In October 2002, Pharmacia initiated phase III trials for RA and at this time Celltech anticipated initiating phase III trials for CD in mid-2003. NCT00544154 Phase 3 in RA started in Oct 2002, but the record is retrospective and was first posted on Oct 16, 2007. |
| Full address of company | Allée de la Recherche, 60 1070 Brussels Belgium Europe Belgium https://www.ucb.com/contact |
Fab' - IgG1 kappa
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |