The FDA declined to approve Simponi (golimumab) for use in limiting the advance of structural damage in patients with moderate to severe rheumatoid arthritis.
Janssen Biotech announced last Friday that the FDA had declined to approve its drug Simponi (golimumab) for use in limiting the advance of structural damage in patients with moderate to severe rheumatoid arthritis (RA). The company said in a press release that it would request a meeting with the FDA to discuss the decision and determine what steps it could take to obtain approval.
Simponi is a genetically engineered antibody drug that binds to the TNF-alpha protein in the blood. Some people produce a surplus of the protein, causing inflammation and damage to bones, cartilage, and tissue. The drug was approved by the FDA in 2009 for use in treating moderate to severe RA in conjunction with methotrexate. It was also approved for treating psoriatic arthritis and ankylosing spondylitis.
Simponi was approved in Europe this January and in Japan on July 1 for uses similar to that the FDA declined to approve it for—slowing or preventing structural damage from RA.