FDA staff who participated in the review of Sanofi/Regeneron's sarilumab for rheumatoid arthritis.
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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.
Chronicle of the development and FDA review of Sanofi and Regeneron's interleukin-6 receptor antagonist sarilumab.
Lipid increases in sarilumab's clinical program spurred consideration of a cardiovascular outcomes trial postmarketing requirement akin to that conducted for Genentech's Actemra. However, Medical Policy Council's new subcommittee recommended against requiring a study, citing feasibility concerns.