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FDA Unable to Grant Approval for Baricitinib’s New Drug Application
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In a complete response letter issued to Eli Lilly and Incyte today, the FDA did not approve the new drug application for baricitinib in its current form. Baricitinib is an investigational once-daily oral Janus kinase inhibitor for the treatment of moderate to severe rheumatoid arthritis.
“We are disappointed with this action,” Christi Shaw, president of Lilly Bio-Medicines, said in a company press release. “We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe [rheumatoid arthritis] RA.”
In its letter, the FDA said additional data are needed to determine appropriate dosage and to characterize safety concerns across treatment arms. According to the release, Eli Lilly and Incyte stated they disagree with the FDA’s conclusions and timing of a resubmission will be based on further discussions with the FDA.
In January 2016, Eli Lilly and Incyte submitted the new drug application, and in January 2017 announced the 3-month extension for additional review of data.
“We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the United States,” Shaw said in the release.
Reference: https://investor.lilly.com/releasedetail.cfm?ReleaseID=1021392