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June 29, 2018 0 By CH Unnikrishnan

The US FDA’s Arthritis Advisory Committee recommended the approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

Baricitinib is indicated for adult patients who have had an inadequate response or intolerance to methotrexate.

Baricitinib is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including rheumatoid arthritis.

The Advisory Committee’s recommendation was based on baricitinib’s global development programme, which included four completed Phase 3 studies in 3,492 patients. The studies evaluated baricitinib’s treatment impact related to RA signs and symptoms, physical function, joint damage progression and other patient-reported outcomes.