Lilly to file baricitinib resubmission to FDA before end of January 2018
Resubmission package will include new safety and efficacy data.
Eli Lilly and Incyte Corporation have announced that, after discussions with the FDA in late August, Lilly will resubmit the New Drug Application (NDA) 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 6-month review cycle. Baricitinib is a once-daily oral investigational medication for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA).
"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 US."
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