In a complete response letter to Eli Lilly, the FDA said additional data are needed to determine accurate dosing and further identify safety concerns across treatment areas, according to a company news release.
Eli Lilly said it disagrees with the FDA’s decision and plans to hold further discussions with the agency before resubmitting the drug for approval.
“We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S,” said Christi Shaw, president of Lilly Bio-Medicines.
Eli Lilly’s shares fell 4 percent Monday morning following news of the denial, reports CNBC. Incyte, which developed the drug with Eli Lilly, saw its stock drop nearly 11 percent. Wall Street analysts project the treatment to produce more than $1 billion in sales by 2020 if it had been approved, according to Bloomberg data.
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