The FDA Arthritis Advisory Committee has voted to deny the Biologics License Application (BLA) approval of Johnson & Johnson’s sirukumab (Plivensia) for the treatment of adults with moderate to severe rheumatoid arthritis (RA) who had displayed an insufficient response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
Prior to the Arthritis Advisory Committee meeting on Aug. 2, the FDA released documents stating the importance of drug safety, especially the