US FDA Panel Weighs Design Of A Pre-approval Safety Study For Janssen's Sirukumab

08 Aug 2017

IL-6 inhibitor should be compared to another biologic to exclude a multi-fold increase in the risk of death, advisers say; FDA assures the panel's industry representative it is not considering an across-the-board requirement for large safety studies of rheumatoid arthritis treatments.

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...