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# FDA Panel ‘Thumbs Down’ on Janssen Arthritis Drug
- URL: https://www.fdaweb.com/fda-panel-thumbs-down-on-janssen-arthritis-drug/
- Published: 2017-08-03T12:00:00.000Z
- Updated: 2026-09-14T22:38:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139299

FDA’s Arthritis Advisory Committee has voted 12 to 1 against recommending approval of a Janssen Biotech BLA for Plivensia (sirukumab), citing safety concerns raised in an FDA [briefing document](https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM569150.pdf?ref=fdaweb.com) released in advance of the meeting. Its major safety findings were related to immunosuppression consistent with other disease-modifying anti-rheumatic drugs, but the reviewers also saw a trend of increased overall mortality with the therapy over placebo, according to the document. The common causes of mortality were major adverse cardiovascular events, infection and malignancy, it said.