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Lilly's Baricitinib: US FDA Panel To Weigh Thrombosis Risk, Dose Selection

Executive Summary

Agency remains skeptical of JAK inhibitor's risk/benefit profile in rheumatoid arthritis even after Lilly submitted Sentinel network data showing baricinitib does not present an increased risk of thromboembolic events among RA patients; review documents suggest need to show an efficacy or safety benefit relative to other RA treatments, particularly Pfizer's Xeljanz.

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

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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