Lilly, Incyte Disagree with FDA Rejection on Arthritis Drug

Eli Lilly and Incyte say they disagree with an FDA complete response letter requesting additional data for their NDA for baricitinib, a once-daily oral medication for treating moderate-to-severe rheumatoid arthritis. The letter indicated that additional clinical data are needed to further characterize safety concerns across treatment arms, and to determine the most appropriate doses. The timing of a resubmission will be based on further talks with the agency, according to the companies.

Lilly and Incyte submitted the NDA 1/2016, and they announced in January an FDA three-month extension to allow time to review additional data analyses. Baricitinib is a once-daily oral JAK inhibitor being evaluated for inflammatory and autoimmune diseases. In 2009, Lilly and Incyte announced a license and collaboration agreement for developing baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.