Eli Lilly and Company and Incyte Corporation have announced that the US Food and Drug Administration (FDA) has approved the 2-mg dose of Olumiant (baricitinib)—a once-daily, oral, Janus kinase (JAK) inhibitor—for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to ≥1 tumor necrosis factor (TNF) inhibitor therapies. Olumiant may be used as monotherapy or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs DMARDs. However, use of Olumiant in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
Eli Lilly and Company is headquartered in Indianapolis, IN; Incyte Corporation is based in Wilmington, DE.
Adverse reactions: Adverse reactions (≥1%) include upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
FDA approves Olumiant (baricitinib) 2-mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis. [news release]. Indianapolis, IN: Eli Lilly and Company, and Wilmington, DE: Incyte Corporation. June 1, 2018. https://investor.lilly.com/news-releases/news-release-details/fda-approves-olumiantr-baricitinib-2-mg-tablets-treatment-adults. Accessed July 3, 2018.
This Week's Must Reads
Must Reads in FDA Actions
FDA Approves Gloperba Oral Solution for Gout Flares, FirstWord Pharma news release; 2019 Feb 26
FDA Approves Hyrimoz for Chronic Conditions, Sandoz news release; 2018 Oct 31
FDA Approves Subcutaneous Actemra for Active SJIA, PharmaLive news release; 2018 Sep 13
FDA Approves Olumiant for Rheumatoid Arthritis, Eli Lilly, Incyte news release; 2018 Jun 1
FDA Approves Consensi for Osteoarthritis Pain, FirstWord Pharma news release; 2018 May 31