FDA panel votes against sirukumab approval

FDA's Arthritis Advisory Committee (AAC) voted 12-1 against approval of sirukumab (CNTO 136) from Johnson & Johnson (NYSE:JNJ) to treat moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The committee based its decision on the safety profile of the human IgG1 kappa mAb against IL-6.

The committee voted 13-0 that J&J’s data provides “substantial evidence” of sirukumab’s efficacy, but voted 11-2 that its safety profile is not "adequate" to support approval. FDA asked committee members to discuss Phase III data which showed an imbalance in all-cause mortality between sirukumab and placebo (see BioCentury Extra, July 31)...