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. 2015 Sep 18;36(6):1110–1122. doi: 10.3109/07388551.2015.1084266

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  Drotrecogin alfa Severe septicemia/septic shock Approved 2001;  withdrawn 2011 Approved 2002;  withdrawn 2011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  Epoetin delta Anemia secondary to chronic renal failure NA Approved 2002;  withdrawn 2009 (Europe)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).