Another delay for baricitinib as FDA calls for more clinical data

The US Food and Drug Administration has issued a complete response letter for the New Drug Application (NDA) of the investigational medicine baricitinib, a once-daily oral JAK inhibitor for the treatment of moderate-to-severe rheumatoid arthritis (RA), reported the drug’s developers, Eli Lilly (NYSE: LLY) and Incyte (Nasdaq: INCY).

The letter indicates that the FDA is unable to approve the application in its current form. Specifically, the agency 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.

There was no immediate investors’ response to the news as stock markets in the USA and many other countries were closed on Friday. However, by late-morning trading on Monday Incyte was down 10.95% to $125.42 and Lilly declined 3.97% to $82.47.