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
Burden of Sexual Dysfunction in Women with RA, J Rheumatol; ePub 2018 Sep 1; Puchner, et al
Medication Beliefs, Self-Efficacy Examined in RA, J Rheumatol; ePub 2018 Sep 15; McCulley, et al
Physical Activity Maintenance in Patients with RA, J Rheumatol; 2018 Aug; Nordgren, Fridén, et al
Effects of Flares in RA with Low Disease Activity, J Rheumatol; ePub 2018 Sep 1; Bechman, et al
RF and ACPAs Observed as Markers for Clinical RA, Clin Immunol; 2018 Oct; Lingampalli, et al
Must Reads in FDA Actions
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
FDA Approves Prolia for GIOP in Men and Women, FirstWord Pharma news release; 2018 May 21
FDA Approves Xeljanz/Xeljanz XR for Adult PsA, Pfizer news release; 2017 Dec 14
FDA Approves New Pfizer Biosimilar Ixifi, Pfizer news release; 2017 Dec 13