Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration will not meet the Prescription Drug User Fee Act action date for the supplemental new drug application for baricitinib for the treatment of adults with moderate to severe atopic dermatitis. The delay is related to the FDA's ongoing assessment of JAK inhibitors. Baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, is approved for the treatment of adults with moderately to severely active rheumatoid arthritis in more than 75 countries.

It is also approved in over 40 countries for the treatment of adults with moderate to severe AD who are candidates for systemic therapy and approved in Japan for the treatment of certain hospitalized patients with COVID-19. Baricitinib is being studied in alopecia areata, systemic lupus erythematosus and juvenile idiopathic arthritis. Indication and Usage for OLUMIANT (baricitinib) tablets for RA patients: OLUMIANT 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs, or with potent immunosuppressants such as azathioprine and cyclosporine.