Table 4.
Monoclonal antibodies in FDA review or approved as treatments for immunological indications
Generic name | Trade name | Target and type | Indication under consideration or first approved | FDA approval year |
Eculizumab | Soliris | Anti-C5; humanized IgG2/4 | Paroxysmal nocturnal hemoglobinuria | 2007 |
Muromonab-CD3 | Orthoclone Okt3 | Anti-CD3; murine IgG2a | Reversal of kidney transplant rejection | 1986 |
Basiliximab | Simulect | Anti-IL2R; chimeric IgG1 | Prevention of kidney transplant rejection | 1998 |
Daclizumab | Zenapax | Anti-IL2R; humanized IgG1 | Prevention of kidney transplant rejection | 1997 |
Efalizumab | Raptiva | Anti-CD11a; humanized IgG1 | Psoriasis | 2003# |
Tocilizumab | Actemra* | Anti-IL6R; humanized IgG1 | Rheumatoid arthritis | Pending |
Ustekinumab | Stelara | Anti-IL12/23; human IgG1 | Psoriasis | 2009 |
Canakinumab | Ilaris | Anti-IL1β; human IgG1 | Muckle-Wells syndrome | 2009 |
Omalizumab | Xolair | Anti-IgE; humanized IgG1 | Asthma | 2003 |
Natalizumab | Tysabri | Anti-α4 integrin; humanized IgG4 | Multiple sclerosis | 2004 |
Golimumab | Simponi | Anti-TNFα; human IgG1 | Rheumatoid and psoriatic arthritis, ankylosing spondylitis | 2009 |
Certolizumab pegol | Cimzia | Anti-TNFα; humanized Fab, pegy-lated | Crohn disease | 2008 |
Adalimumab | Humira | Anti-TNFα; human IgG1 | Rheumatoid arthritis | 2002 |
Infliximab | Remicade | Anti-TNFα; chimeric IgG1 | Crohn disease | 1998 |
Note: Information current as of October 1, 2009; *Proposed trade name; #Voluntarily withdrawn from US market in April 2009; C5, complement 5; CD, cluster of differentiation; FDA, US Food and Drug Administration; IL, interleukin; TNF, tumor necrosis factor.