The US FDA has approved Janssen Biotech's Simponi ARIA (golimumab) for infusion to treat moderately to severely active rheumatoid arthritis (RA).
Simponi ARIA is the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy indicated for the treatment of RA in combination with methotrexate.
The 2mg/kg dose of Simponi ARIA is given as an intravenous infusion over a period of 30 minutes at weeks zero and four, then every eight weeks thereafter.
Janssen Research & Development immunology development head and vice president Jerome Boscia said, "SIMPONI ARIA demonstrated a compelling efficacy profile in the treatment of moderately to severely active rheumatoid arthritis in the GO-FURTHER study."
Data from Phase III trial of Golimumab, an anti-TNF-alpha monoclonal antibody, administered intravenously, in subjects with active rheumatoid arthritis despite methotrexate therapy (GO-FURTHER), formed the basis for FDA approval.
Janssen Biotech president Rob Bazemore said, "Treatment with SIMPONI ARIA provides a different infusion experience; patients can now receive this form of treatment administration with an anti-TNF therapy via a short infusion time of 30 minutes with a dosing regimen of every 8 weeks."
