Quick Resubmission Has Shire Seeking Third Quarter Lifitegrast OK
This article was originally published in The Pink Sheet Daily
Having produced positive top-line data from a third Phase III trial within two weeks of FDA's complete response letter, Shire made quick work of its reply to the agency on the dry eye disease candidate.
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By examining the "totality of the data" including a Phase II study, FDA approved drug for both measures of dry eye, despite mixed results in pivotal trials.
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With its third acquisition this year, Shire gains Phase III Lifitegrast in development for dry eye disease. It expects to launch the product in the U.S. in 2016.