The FDA has issued a complete response letter regarding the new drug application (NDA) for baricitinib (Eli Lilly/Incyte Corporation), a once-daily oral medication for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA).
The letter indicates that the FDA is unable to approve the application in its current form. Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms. The companies disagree with the agency’s conclusions. The timing of a resubmission will be based on further discussions with the FDA.
Lilly and Incyte submitted the NDA for baricitinib in January 2016. One year later, the two companies announced the FDA’s three-month extension to allow time for review of additional data analyses.
Baricitinib is a Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3, and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including RA.
In December 2009, Lilly and Incyte signed an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. The companies conducted four phase 3 trials of baricitinib in patients with moderate- to-severe, active RA to support regulatory submissions in most countries. Two of the four studies included prespecified comparisons with approved disease-modifying antirheumatic drugs (DMARDs): one with methotrexate (RA-BEGIN) and one with adalimumab (RA-BEAM).
Source: Eli Lilly; April 14, 2017.