FDA has approved Simponi for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis


The FDA ( Food and Drug Administration ) 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.

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-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 TNF-alpha 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-alpha 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.

Source. FDA, 2009

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