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The U.S. Food and Drug Administration approved Simponi (golimumab) on April
24, 2009, a monthly treatment for adults with moderate-to-severe rheumatoid
arthritis, active psoriatic arthritis, and active ankylosing spondylitis. 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.
All three conditions are chronic disorders in which the immune system attacks
multiple joints, causing stiffness, pain, and restricted motion.
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
What are the side effects or warnings of Simponi?
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 FDA Approves Monthly Injectable Drug for Treating Three Types of Immune-
Related Arthritis FDA NEWS RELEASE April 24, 2009