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Baricitinib Complete Response May Put Lilly/Incyte Behind IL-6 Blockers In RA

Executive Summary

FDA complete response letter seeks additional data on dosing and other safety concerns, delaying potential approval for an NDA that already had been pushed back three months. Interleukin-6 inhibitors sarilumab and sirukumab, now under review at FDA, both could obtain approval before baricitinib.

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