Simponi Approved for Immune-Related Arthritis
FRIDAY, April 24 -- Simponi (golimumab) has been approved by the U.S. Food and Drug Administration to treat three forms of arthritis that occur when the body's immune system attacks the joints.
The injected drug, administered once a month, was sanctioned to treat moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis, the agency said in a news release.
It's among a class of drugs that target tumor necrosis factor-alpha (TNF-α). When overproduced, this protein can cause inflammation and damage to bones, cartilage, and tissue. As with similar medicines, Simponi's label will include a so-called "black-box" warning that users face an increased risk of tuberculosis and invasive fungal infections, the FDA said.
Common side effects of the drug include upper respiratory tract infection, sore throat, and nasal congestion.
Simponi is marketed by Pennsylvania-based Centocor Ortho Biotech Inc.
The FDA has more about this approval.
Posted: April 2009