Lilly to Resubmit NDA for Arthritis Drug
Eli Lilly plans to resubmit a new drug application for the anti-inflammatory baricitinib by Jan. 31, 2018.
Lilly and Incyte, its partner in developing baricitinib, sought approval of the drug as a treatment for rheumatoid arthritis in 2016. The FDA said no this past April and, after discussion with the FDA, Lilly said it will present new safety and efficacy data in its resubmission.
The drug was approved this year in the European Union and Japan.