Janssen's Sirukumab Falls On Mortality Concerns At US FDA Panel
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.
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The company said it will pull global regulatory filings for the interleukin-6 inhibitor sirukumab for rheumatoid arthritis after determining regulatory delays would put it too far behind the competition.
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.
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