FDA Delays Baricitinib Decision Save

Eli Lilly and Company and Incyte Corporation announced today that the U.S. Food and Drug Administration (FDA) has delayed its' decision on baricitinib by issuing a complete response letter for baricitinib's New Drug Application. 

Lilly and Incyte originally submitted the NDA for baricitinib to the FDA in January 2016.

In January 2017, the FDA extended the decision date on baricitinib by 3 months to review additional data recently submitted by Lilly. The FDA determined this to be a major amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months.

As the PDUFA data was fast approaching, many anticipated an imminent FDA decision on baricitinib.

The current complete response letter indicates the FDA is unable to approve the application in its current form. The FDA has indicated that additional clinical data is needed to determine the most appropriate doses and better characterize safety concerns.

"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."

Baricitinib is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases and was approved for use in RA in the EU in February 2017.