FDA OKs Simponi for Rheumatoid Arthritis
Drug Is Approved to Treat RA, Psoriatic Arthritis, and Ankylosing Spondylitis
April 24, 2009 -- The FDA has approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, psoriatic arthritis, and 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," says Bob Rappaport, MD, director of the division of anesthesia, analgesia, and rheumatology products in the FDA's Center for Drug Evaluation and Research, in a news release. "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 immune-suppressing 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-alpha), 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 similar drugs, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and serious fungal infections with use of the drug. Other TNF blockers include Enbrel, Humira, and Remicade.
The FDA also required additional information, as it required for other TNF-alpha blockers. This includes a medication guide for patients and a communication plan to help prescribers understand the drug's risks.
The most common side effects of Simponi include upper respiratory tract infection, sore throat, and nasal congestion.