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Eli Lilly, Incyte Corporation to Resubmit New Drug Application for Baricitinib
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Eli Lilly and Company and Incyte Corporation announced Eli Lilly will resubmit the new drug application for baricitinib before the end of January 2018.
According to a company press release, the resubmission package for baricitinib, a once-daily oral investigational medication for the treatment of patients with moderate to severe rheumatoid arthritis (RA), will include new safety and efficacy data. The move comes after discussion with the FDA in late August. The companies anticipate the FDA will classify the application as a class II resubmission, which will start a new 6-month review cycle.
“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,” Christi Shaw, president of Lilly Bio-Medicines, said in the release. “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.”
Reference:
https://investor.lilly.com/releasedetail.cfm?ReleaseID=1038612