The FDA has delayed approving the oral JAK inhibitor baricitinib, saying it needs more clinical data.
The U.S. drug regulator issued manufacturers Incyte and Eli Lilly with a Complete Response Letter stating it needed more information in order to be sure of the correct dosing and to “further characterize safety concerns across treatment arms”.
The announcement follows a three-month extension period of the review on the drug used to treat moderate to severe rheumatoid arthritis.
The drug’s developers say they are disappointed with the regulatory body’s decision.
“ We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” said Christi Shaw, president of Lilly Bio-Medicines in a press release.
“We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”