Posted by Michael Wonder on 30 Aug 2017
Lilly to file baricitinib resubmission to U.S. FDA before end of January 2018
30 August 2017 - Eli Lilly and Company and Incyte Corporation announced today that, after discussions with the U.S. FDA in late August, Lilly will resubmit the new drug application for baricitinib before the end of January 2018.
The resubmission package will include new safety and efficacy data. The companies anticipate the FDA will classify the application as a Class II resubmission, which will start a new six-month review cycle. Baricitinib is a once-daily oral investigational medication for the treatment of patients with moderate-to-severe rheumatoid arthritis.
