FDA OKs New Arthritis Drug

The U.S. Food and Drug Administration says it has approved Simponi, a monthly injectable treatment for three types of arthritis.

The FDA said Simponi (golimumab) was approved for use by adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain and restricted motion.

"Today's approval provides another treatment option for patients with these three debilitating disorders," said Dr. Bob Rappaport, director of the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products. "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 is injected under the skin, the federal agency said. It is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.

Simponi is marketed by Centocor Ortho Biotech Inc. of Malvern, Pa.