Posted by Michael Wonder on 13 Dec 2018
FDA grants fast track designation to the baricitinib development program for the treatment of systemic lupus erythematosus
13 December 2018 - Eli Lilly and Incyte announced today that the U.S. FDA has granted fast track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus.
Earlier this year, positive results of a Phase 2 study of baricitinib for the treatment of SLE, which informed the FDA's Fast Track designation, were published by The Lancet and presented at the European Congress of Rheumatology.
Lilly is currently studying two doses of baricitinib in Phase 3 SLE trials. Additionally, Lilly is investigating baricitinib as a potential treatment for moderate to severe atopic dermatitis, a serious form of eczema, with Phase 3 results projected to be shared during the first half of 2019. Baricitinib is approved in over 50 countries globally as Olumiant for the treatment of adults with rheumatoid arthritis.
