Second JAK Inhibitor Drug for RA Approved by FDA
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved Incyte Corp.’s Olumiant (baricitinib) 2 mg once-daily oral medication to treat adults with moderately to severe active rheumatoid arthritis (RA). Olumiant is the second oral janus kinase (JAK) inhibitor approved for RA in the U.S., following approval of Pfizer’s Xeljanz (tofacitinib) in November 2012. It is indicated for patients who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. However, approval of Olumiant comes with a boxed warning for the risk of serious infections, malignancies and thrombosis.
In April, FDA declined to approve the 4 mg dose of Olumiant after an independent advisory panel voted against it over concerns related to its safety profile.
References
FDA Approval of Low Dose RA Drug Olumiant Gives Eli Lilly and Incyte Edgein Immediate Future. Global Data press release, June 18, 2018. Accessed at www.drugs.com/newdrugs/fda-approves-olumiantbaricitinib-2-mg-adults-moderately-severely-active-rheumatoidarthritis-4760.html.
