FDA approves Simponi Aria (Janssen Biotech) infusion for Rheumatoid Arthritis

The FDA has approved Simponi Aria (golimumab), from Janssen Biotech, for infusion for the treatment of adults with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate. FDA approval is supported by data from the Phase III GO-FURTHER trial, which evaluated 592 patients with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline, had elevated C-reactive protein (CRP) levels at screening and who had been receiving background methotrexate for at least three months.

Results revealed 59% of patients receiving Simponi Aria plus methotrexate versus 25% of patients on placebo plus methotrexate experienced significant improvements in signs and symptoms at week 14, as demonstrated by at least 20% improvement in American College of Rheumatology criteria (ACR 20), the study's primary endpoint. A higher proportion of patients receiving Simponi Aria plus methotrexate achieved at least a 50 percent improvement in ACR 50 compared with placebo plus methotrexate at week 14 (30% versus 9%).