Janssen's Sirukumab Brings Mortality Imbalance Into FDA Panel Review
Unfavorable trends in all-cause death, malignancy and major adverse cardiovascular events are key safety issues facing US agency's Arthritis Advisory Committee, which also is being asked to weigh adequacy of Janssen's dose selection and, more generally, use of long-term placebo controls in rheumatoid arthritis studies.
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Although lengthy duration of placebo treatment was not flagged for concern in first-cycle review of Sanofi/Regeneron's sarilumab for rheumatoid arthritis, it drew considerable attention in the BLA's second go-around at FDA, which included an ethics consult and a center director briefing.
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.
Full data for the Phase III SIRROUND-D study of GlaxoSmithKline PLC/Janssen Pharmaceuticals Inc.'s sirukumab show early and good separation over placebo in rheumatoid arthritis, but the third-placed anti-IL6 product will have to work hard to catch up with its more advanced rivals, Actemra (tocilizumab) and sarilumab.