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BRIEF-U.S. FDA issues CRL for baricitinib
2017年4月14日 / 下午1点06分 / 7 个月前

BRIEF-U.S. FDA issues CRL for baricitinib

April 14 (Reuters) - Incyte Corp:

* U.S. FDA issues complete response letter for baricitinib

* Letter indicates that FDA is unable to approve application in its current form

* Specifically, FDA indicated that additional clinical data are needed to determine most appropriate doses

* FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms

* “Companies disagree with agency’s conclusions”

* Incyte is evaluating impact of complete response on its previously-issued milestone and research and development expense guidance for 2017

* Lilly is reaffirming both its financial guidance for 2017 and its mid-term guidance for remainder of this decade Source text for Eikon: Further company coverage:

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