The US FDA could require Janssen Biotech Inc. to conduct a preapproval, comparative safety study of its interleukin-6 inhibitor Plivensia (sirukumab) due to a mortality imbalance in the pivotal trials, but agency staff said they are not contemplating an across-the-board study requirement for similar products.
At their Aug. 2 review of sirukumab for rheumatoid arthritis (RA), members of FDA's Arthritis Advisory Committee said the currently...
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