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FDAnews Drug Daily Bulletin
Sept. 26, 2012 | Vol. 9 No. 189
Janssen Submits IV Simponi for Moderate to Severe RA
Janssen Biotech has submitted a BLA seeking approval of an IV formulation of Simponi to treat adults with moderate to severe rheumatoid arthritis (RA). The Johnson & Johnson subsidiary’s BLA is supported by a Phase III trial that found nearly 60 percent of patients receiving Simponi (golimumab), a tumor necrosis factor (TNF) blocker, achieved a 20 percent improvement in arthritis signs and symptoms at week 14. The company previously applied for EU approval for the same RA indication.
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