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Rheumatoid Arthritis: Sirukumab Presents Safety Issues

Update: FDA does not recommend approval of sirukumab

Update: FDA does not recommend approval of sirukumab

On August 2, 2017, it was announced by Janssen Biotech, Inc. that the FDA's Arthritis Advisory Committee will not recommend that the FDA approve sirukumab (or Plivensia) as a viable therapy in the treatment of moderately to severely active RA. The decision comes regardless to whether or not an RA patient has been unresponsive or intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Sirukumab, which is a monoclonal antibody that blocks interleukin 6 (IL-6) in a manner that is slightly different from other previously approved therapies was submitted for approval to the FDA on September 23, 2016.