Janssen's Sirukumab Falls On Mortality Concerns At US FDA Panel

03 Aug 2017

But advisory committee members suggest narrower indication might have won their support. In recommending against approval for rheumatoid arthritis, panelist were uncertain whether imbalance in deaths in the placebo-controlled trials resulted from an artifact of trial design or a real safety signal.

Residual uncertainty about a mortality imbalance in clinical trials of Janssen Biotech Inc.'s rheumatoid arthritis (RA) treatment Plivensia (sirukumab) proved too much to overcome for FDA's Arthritis Advisory Committee members Aug. 2.

The panel voted 12-1 against approval of the interleukin-6-targeted biologic for the treatment of adults with moderately to severely active...