Translation of the bolded sentence above: “We hope the FDA will listen to the advisory panel and approve CT-P13 for all five approved indications of branded Remicade (Crohn's disease, ulcerative colitis, RA, ankylosing spondylitis, psoriatic arthritis, and psoriasis), even through we conducted clinical trials in only two of those indications (RA and ankylosing spondylitis).”
Branded Remicade has six FDA-approved indications (not five)—the ones enumerated above.
Developed by Celltrion, this is the same product that just won the endorsement of an FDA advisory committee (#msg-120426130). PFE’s divestiture of the EU rights to this compound was an EU condition for approving the PFE-HSP merger.