Posted by Michael Wonder on 28 Jan 2022
Updates on Olumiant (baricitinib) FDA review for atopic dermatitis
28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in adults with active systemic lupus erythematosus and the status of the U.S. atopic dermatitis supplemental new drug application.
Lilly is in ongoing discussion with the U.S. FDA regarding the status of the supplemental new drug application for Olumiant for the treatment of adults with moderate to severe atopic dermatitis. At this point, the company does not have alignment with the FDA on the indicated population.
Given the Agency's position, there is a possibility that this could lead to a complete response letter.
