FDA flags deaths, dosing ahead of sirukumab panel

In briefing documents released ahead of a planned advisory committee meeting, FDA reviewers raised concerns about a trend towards increased mortality seen with rheumatoid arthritis candidate sirukumab (CNTO 136) compared to placebo.

FDA's Arthritis Advisory Committee (AAC) is to meet Wednesday to discuss a BLA in which Johnson & Johnson (NYSE:JNJ) is seeking approval of the human IgG1 kappa mAb against IL-6 to treat adults with moderately to severely active RA who are intolerant or respond inadequately to disease-modifying anti-rheumatic drugs (DMARDs). Sirukumab's PDUFA date is Sept. 22...