FDA Approves Monthly Injectable Drug For Treating Three Types Of Immune-Related Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Apr 2009 - 5:00 PDT

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The U.S. Food and Drug Administration today approved Simponi (golimumab), a monthly treatment for 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 Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research. "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. 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.

In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.

Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. Like other TNF- α blockers, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and invasive fungal infections with use of the drug. The FDA also required a risk evaluation mitigation strategy (REMS) for Simponi, as it required for other TNF-α blockers. The REMS for Simponi includes a Medication Guide for patients and a communication plan to help prescriber's understand the drug's risks.

The most common adverse reactions to Simponi include upper respiratory tract infection, sore throat and nasal congestion.

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

Source
U.S. Food and Drug Administration