Rheumatoid arthritis

FDA delays approval on JAK inhibitor

Tuesday, 18 Apr 2017


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.”

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