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Baricitinib Complete Response May Put Lilly/Incyte Behind IL-6 Blockers In RA

 
• By Joseph Haas

FDA complete response letter seeks additional data on dosing and other safety concerns, delaying potential approval for an NDA that already had been pushed back three months. Interleukin-6 inhibitors sarilumab and sirukumab, now under review at FDA, both could obtain approval before baricitinib.

Film x-ray knee joint with arthritis

Eli Lilly & Co. and Incyte Corp.'s hopes to bring their oral selective JAK1/2 inhibitor baricitinib to market soon in rheumatoid arthritis were dashed by an FDA complete response letter announced April 14, potentially putting a pair of interleukin-6 inhibitors now under review by the US regulator ahead in the race to get new RA therapies approved.

Filed for approval in January 2016, baricitinib initially had a January 2017 user fee deadline, but that was pushed back...

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