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# Lilly, Incyte Disagree with FDA Rejection on Arthritis Drug
- URL: https://www.fdaweb.com/lilly-incyte-disagree-with-fda-rejection-on-arthritis-drug/
- Published: 2017-04-14T12:00:00.000Z
- Updated: 2026-09-14T22:17:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138454

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.