Janssen's Sirukumab Brings Mortality Imbalance Into FDA Panel Review
Executive Summary
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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