Olumiant Approved to Treat Rheumatoid Arthritis
June 1, 2018 – The U.S. FDA has approved Olumiant® (baricitinib), manufactured by Eli Lilly and Incyte, for the treatment of moderate-to-severe active rheumatoid arthritis in adults whose condition has not been well-managed by one or more tumor necrosis factor (TNF) inhibitors.
Olumiant is a Janus kinase (JAK) inhibitor, and works by blocking pathways that carry inflammatory signals within cells. It can be used either alone or in conjunction with methotrexate or other disease-modifying antirheumatic drugs (DMARDs). Recommended dosing is 2mg once daily.
A black box warning indicates that Olumiant may increase the risk of serious infection. Patients should be tested for tuberculosis before starting treatment. The boxed warning also cautions that Olumiant has been associated with lymphoma and other cancers, as well as potentially fatal thrombosis.
Only two other JAK inhibitors are currently available in the United States: Pfizer’s Xeljanz® (tofacitinib) and Xeljanz® XR (tofacitinib, extended-release). Eli Lilly and Incyte have launched Olumiant at an average wholesale price of $2,465.64 per month.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.