Arthritis News: Golimumab Receives FDA Approval

FDA

FDA

Approval for golimumab (which will by marketed under the trade name Simponi) was granted this week by the U.S. Food and Drug Administration.  The drug received approval for the treatment of moderate to severe RA (in conjunction with methotrexate), active psoriatic arthritis (as monotherapy or with methotrexate), and active ankylosing spondylitis at a dose of 50 mg injected monthly for all three conditions.  The drug, a humanized monoclonal antibody that neutralizes TNF-α, is the fourth TNF inhibitor approved to treat these conditions and the third that is self-injected.  As with the other approved TNF inhibitors, the FDA has included a black box warning regarding the potential for reactivation of tuberculosis and invasive fungal infections.  Summaries of golimumab publications  and scientific abstracts for the treatment of RA previously included on this website are available to review.

Jon Giles, MD

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