Lilly, Incyte to Refile Baricitinib NDA

Lilly and Incyte say they will resubmit their NDA for baricitinib, including new safety and efficacy data, before the end of 1/2018. The decision follows discussions with FDA at the end of August, the companies say. They expect the agency will classify the application as a Class 2 resubmission, starting a new six-month review cycle. Baricitinib is described as a once-daily oral investigational drug to treat patients with moderate to severe rheumatoid arthritis.

In April, the companies said they disagreed with an FDA complete response letter requesting additional data for the NDA. The letter said that additional clinical data were needed to further characterize safety concerns across treatment arms, and to determine the most appropriate doses.

Lilly and Incyte submitted the NDA 1/2016 and announced 1/2017 an FDA three-month extension to allow time to review additional data analyses.