Lilly and Incyte provide update on supplemental NDA for baricitinib for the treatment of moderate to severe atopic dermatitis

Eli Lilly and Company and Incyte announced that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action date for the supplemental new drug application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). 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 (RA) 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 (AA), systemic lupus erythematosus (SLE) and juvenile idiopathic arthritis (JIA).