The U.S. Food and Drug Administration has issued a letter in response to the New Drug Application for baricitinib, rejecting the application, proposed as a daily treatment for moderate-to-severe rheumatoid arthritis.
The FDA stated multiple reasons for its rejection, such as the need for more information and data in order to confirm the safety of the medication.
"We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA," Cristi Shaw, president of Lilly Bio-Medicines, said.
Shaw said the company would continue to consult the FDA and that the drug would eventually be available to patients located the U.S. She noted the drug was introduced to the FDA in January 2016, and it was not until January 2017 that the FDA requested three additional months to come to its conclusion.
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