Indianapolis-based Eli Lilly and Co. (NYSE: LLY) and Delaware-based Incyte Corp. (Nasdaq: INCY) have announced plans to resubmit the New Drug Application for a once-daily treatment for rheumatoid arthritis. In April, the U.S. Food and Drug Administration rejected an NDA for baricitinib, saying more clinical results were needed.
Lilly says the resubmission package, which will be provided to the FDA before the end of January 2018, will include new safety and efficacy data. The companies expect the FDA to classify the application as a Class II resubmission, which means a new six-month review cycle will begin.
"We are committed to making life better for people living with RA. There is a significant unmet need for Americans suffering from this debilitating disease in spite of available therapies," said Christi Shaw, president of Lilly Bio-Medicines. "We are pleased with the opportunity to provide our resubmission package for baricitinib sooner than anticipated and look forward to continuing to work with the FDA as we seek to bring baricitinib to people with RA in the U.S."
Lilly and Incyte submitted the original NDA in January 2016. The following March, the companies published results from a Phase 3 global study in the New England Journal of Medicine, showing the drug met its primary endpoint.
In July, the Japan Ministry of Health, Labor and Welfare granted marketing approval for the drug, also known as Olumiant, based on four Phase 3 clinical trials.