Eli Lilly and Incyte Corporation have announced the U.S. Food and Drug Administration (FDA) has issued a response letter for the New Drug Application of the investigational medicine baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis.
The letter indicates that the FDA is unable to approve the application in its current form. The FDA indicated additional clinical data are needed to determine the most appropriate doses. Additionally, the FDA stated 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.
"We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA," said Christi Shaw, president of Lilly Bio-Medicines. "We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S."
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.