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

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.