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

 
• By Sue Sutter

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.

film x-ray both human's hands and arthritis at multiple joint (Gout,Rheumatoid)

Eli Lilly & Co.'s new drug application (NDA) resubmission for the rheumatoid arthritis treatment Olumiant (baracitinib) appears to have done little to assuage the US FDA's first-cycle concerns about the oral JAK inhibitor's thrombosis risk, and the adequacy of the sponsor's dose selection, ahead of an Arthritis Advisory Committee review April 23.

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