Table 2. Human cells lines and their therapeutic protein productsa,b.
Cell line | Product | Indication | FDA approval status | EMA approval status |
---|---|---|---|---|
HEK293 | ||||
Drotrecogin alfa | Severe septicemia/septic shock | Approved 2001; withdrawn 2011 | Approved 2002; withdrawn 2011 | |
rFVIIIFc | Hemophilia A | Approved 2014 | Submitted 2014 | |
rFIXFc | Hemophilia B | Approved 2014 | NA | |
Dulaglutide | Type 2 diabetes | Approved 2014 | Submitted 2014 | |
Human-cl rhFVIII | Hemophilia A | Submitted to the FDA | Approved 2014 | |
HT-1080 | ||||
Agalsidase alfa | Fabry disease | NA | Approved 2001 | |
Epoetin delta | Anemia secondary to chronic renal failure | NA | Approved 2002; withdrawn 2009 (Europe) | |
Idursulfase | Hunter syndrome | Approved 2006 | Approved 2007 | |
Velaglucerase alfa | Type 1 Gaucher disease | Approved 2010 | Approved 2010 | |
PER.C6 | ||||
CL184 | Rabies virus infection | Submitted to the FDA | NA | |
MOR103 | Rheumatoid arthritis, multiple sclerosis | Phase 1 clinical development | Phase 1 clinical development |
FDA, US Food and Drug Administration; EMA, European Medicines Agency; HEK, human embryonic kidney; NA, not approved; rFVIIIFc, recombinant factor VIII Fc fusion protein; rFIXFc, recombinant factor IX Fc fusion protein; rhFVIII, recombinant human factor VIII.
aData obtained from publically available resources (October 2014); all approved products may not be included.
bReferences: (ALPROLIX®, 2014; Bakker et al., 2005; Behrens et al., 2014; Casademunt et al., 2012; DYNEPO®, 2007; ELAPRASE®, 2012, 2013; ELOCTATE®, 2014; European Medicines Agency and Committee for Medicinal Products for Human Use, 2014; Glaesner et al., 2010; Octapharma, 2014; REPLAGAL®, 2006; TRULICITY™, 2014; VPRIV®, 2010a,b; XIGRIS®, 2008).