The Committee will discuss new drug application (NDA) 207924, for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The discussion will include the following: efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations.
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Earlier Event: April 19Peripheral and Central Nervous System Drugs Committee
Later Event: April 23Science Board to FDA