Eli Lilly & Co. is seeking US FDA approval for baricitinib to treat adults with moderate to severe rheumatoid arthritis (RA) who have inadequately responded to or cannot tolerate methotrexate, but members of the agency's Arthritis Advisory Committee suggested on April 23 that the JAK1/2 inhibitor's risk-benefit profile could limit the drug's market.
Lilly May Need To Reassess Baricitinib Market After FDA Advisory Committee
During a mixed review by the US FDA's Arthritis Advisory Committee, panelists suggested that risks potentially associated with Lilly/Incyte's JAK inhibitor would be acceptable for a more limited patient population.
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