Leonard H. Calabrese, DO
The FDA Arthritis Advisory Committee voted 10 to 5 to recommend approval of a once-daily 2-mg dose of baricitinib for the treatment of adults with moderate to severe rheumatoid arthritis who have had an inadequate response to methotrexate.
Although the committee was near-unanimous on the positive efficacy of baricitinib (Olumiant, Incyte & Eli Lilly), its safety was much more controversial, with just a 9-member majority agreeing that the available data supported the safety of the 2-mg dose.
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