Posted by Michael Wonder on 02 Jun 2018
FDA approves Olumiant (baricitinib) 2 mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis
1 June 2018 - The approval of Olumiant is based on the Phase 3 clinical trial program that demonstrated efficacy for difficult to treat patients.
Eli Lilly and Incyte announced today that the U.S. FDA has approved the 2 mg dose of Olumiant (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumour necrosis factor inhibitor therapies.
Use of Olumiant in combination with other Janus kinase inhibitors or biologic disease-modifying anti-rheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. Olumiant may be used as monotherapy or in combination with methotrexate (MTX) or other non-biologic DMARDs.
