Eli Lilly and partner, Incyte Corp., announced that the U.S. FDA did not approve baricitinib, a new treatment for rheumatoid arthritis.
The FDA indicated that additional clinical data is needed to determine the most appropriate doses and to further characterize safety concerns.
Baricitinib is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. Lilly and Incyte submitted the NDA for baricitinib to the FDA in January 2016, and in January 2017 announced the FDA's three-month extension to allow time for review of additional data analyses.
The companies plan to resubmit after further discussions with the FDA.
Read the Eli Lilly press release