FDA Approves Baricitinib Safety-Label Revisions for RA

Key Takeaways

• In the U.S. rheumatoid arthritis setting, FDA approved OLUMIANT (baricitinib) safety-label revisions informed by RA safety studies, including boxed-warning coverage of thrombosis and malignancies.
• Updated warnings address serious infections and major adverse cardiovascular events, alongside changes to patient-facing materials.
• FDA determined that the long-term rheumatoid arthritis safety postmarketing requirement was fulfilled.

For patients receiving baricitinib for rheumatoid arthritis (RA), the scope of safety information on thrombosis, malignancy, serious infections, and cardiovascular events matters when interpreting treatment risks. The Food and Drug Administration (FDA) examined which warnings and patient-facing materials the supplemental application would address.

FDA considered a prior-approval supplement for OLUMIANT (baricitinib) tablets, new drug application (NDA) 207924/S-010, dated and received December 12, 2025. In its baricitinib supplemental approval letter, FDA identified RA Safety Studies 1 and 2 as the basis for the proposed revisions.

FDA approved the OLUMIANT safety-labeling supplement effective October 9, 2026, the date of the letter’s electronic signature. The revised Boxed Warning covers thrombosis and malignancies. The affected Warnings and Precautions include Section 5.3, Malignancy and Lymphoproliferative Disorders, and Section 5.5, Thrombosis.

FDA also identified updates to Warnings and Precautions Section 5.1, Serious Infections, and Section 5.4, Major Adverse Cardiovascular Events. Revisions extend to Clinical Studies Section 14.4, Patient Counseling Information Section 17, and the Medication Guide. After reviewing the final report, FDA determined that postmarketing requirement 3421-1 was fulfilled.