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Lilly's Baricitinib Wins US FDA Panel Thumbs Up For One Of Two Doses

Executive Summary

Despite concerns about small size of safety database, Arthritis Advisory Committee endorses 2 mg dose; panel recommends against approval of 4 mg dose due to stronger thrombosis signal in clinical trials, brushing back Lilly's attempt to position the higher dose as having a positive benefit-risk profile in patients with more refractory disease.

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Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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