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# FDA Approves Lilly/Incyte Arthritis Drug
- URL: https://www.fdaweb.com/fda-approves-lilly-incyte-arthritis-drug/
- Published: 2018-06-01T12:00:00.000Z
- Updated: 2026-09-15T00:09:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141580

FDA has approved an Eli Lilly and Incyte NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. Approval is based on data from the RA-BEACON study, a randomized, double-blind, placebo-controlled study in 527 patients who had an inadequate response or intolerance to one or more TNF inhibitor therapies. Study results showed that significantly higher response rates and improvement in all individual component scores were observed at week 12 with Olumiant-treated patients, the companies say. The approval also carries a Boxed Warning for the risk of serious infections, malignancies and thrombosis. “Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving Olumiant,” they say.