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Refiling of U.S. marketing application for arthritis med baricitinib at least 18 months away, Lilly down 1%, Incyte down 4% premarket

Published 07/25/2017, 07:25 AM
© Reuters.  Refiling of U.S. marketing application for arthritis med baricitinib at least 18 months away, Lilly down 1%, Incyte down 4% premarket
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  • Eli Lilly (NYSE:LLY) is down 1% premarket and development partner Incyte (NASDAQ:INCY) is down 4%, both on light volume, on the heels of the news that Lilly does not anticipate resubmitting its New Drug Application (NDA) for rheumatoid arthritis (RA) med baricitinib to the FDA for at least 18 months.
  • Lilly received a CRL in April citing the need for a new clinical trial to further characterize the benefit/risk profile across doses due to the observed imbalance in thromboembolic events that occurred during the placebo-controlled studies.
  • President of Lilly Bio-Medicines Christi Shaw says, "We disagree with the FDA's conclusions, and believe the existing comprehensive clinical data demonstrate there is a positive benefit/risk profile that supports baricitinib's approval as a new treatment option for people suffering from RA in the United States. We are disappointed that resubmission will not occur this year, but are committed to bringing baricitinib to people with RA and we will work with the FDA on the path forward."
  • Previously: FDA rejects Lilly's marketing application for RA candidate baricitinib (April 14)
  • Now read: Lilly Hopes To Bloom Through Nektar Attraction


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