FDA approves Johnson & Johnson’s Simponi to treat arthritis

ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating three types of arthritis.

The agency announced Friday that it had approved Johnson & Johnson’s Simponi (golimumab), a once-monthly injection for treating moderate-to-severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, an arthritis of the spine.

“[Today’s] approval provides another treatment option for patients with these three debilitating disorders,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class.”

Simponi, a monoclonal antibody made by J&J biologics division Centocor Ortho Biotech, is designed for use in combination with Barr Labs’ immunosuppressant drug Trexall (methotrexate) when treating rheumatoid arthritis, with or without Trexall when treating psoriatic arthritis and alone when treating ankylosing spondylitis.