Lilly : FDA Delays Review Of Baricitinib SNDA On Atopic Dermatitis

(RTTNews) - The U.S. Food and Drug Administration will not meet the Prescription Drug User Fee Act or PDUFA action date for the supplemental new drug application or sNDA 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, Eli Lilly and Co. (LLY) and Incyte (INCY) said in a statement.

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.

Earlier today, AbbVie (ABBV) said that the U.S. Food and Drug Administration did not meet the Prescription Drug User Fee Act or PDUFA action date for the supplemental New Drug Application or sNDA for RINVOQ or upadacitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis.

AbbVie said that the FDA did not take any formal regulatory action on the sNDAs for RINVOQ in atopic dermatitis, psoriatic arthritis or ankylosing spondylitis.