Too much uncertainty
Newman Yeilding, M.D., the Head of Immunology Development at Janssen Research & Development, LLC stated that the organization appreciates the thoughtful review and discussion of the advisory committee concerning the safety and efficacy of sirukumab. The committee agreed unanimously that sirukumab was indeed effective, they stated uncertainty when discussing the safety of the drug. The committee carefully reviewed all available data concerning the drug, and ultimately decided that they were too uncertain about the safety of the drug. Yielding states that the developers appreciated the committee's time and concern but disagreed with their interpretation of the drug's risk when compared with its benefit. Yeilding remains confident in the data collected that he believes shows that sirukumab is safe and effective in the treatment of moderately to severely active RA and still feels that the drug should remain a viable option for RA patients who have been unable to find alternative treatments.