FDAnews Drug Daily Bulletin

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.
Washington Drug Letter