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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 three months by FDA to allow for additional data analysis. With the complete response letter, the drug Lilly and Incyte have partnered on since 2009 looks likely to reach market after GlaxoSmithKline PLC/Janssen Pharmaceuticals Inc

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