Posted by Michael Wonder on 25 Jul 2017
Lilly and Incyte provide update on baricitinib
25 July 2017 - Eli Lilly and Incyte Corporation announced today that a resubmission to the U.S. FDA for the new drug application for baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis, will be delayed beyond 2017.
The companies will be further discussing the path forward with the agency and evaluating options for resubmission, including the potential for an additional clinical study, as requested by the FDA.
The length of time to a resubmission for the application will depend on which option the companies pursue and further FDA discussions, but is anticipated to be a minimum of 18 months.
