9th Apr 2015 17:24
LONDON (Alliance News) - Shire PLC said Thursday that its new drug application for lifitegrast, a treatment for dry eye disease in adults, has been granted a priority review designation by the US Food and Drug Administration.
This designation means that the new drug application has a review target of eight months, compared to the standard twelve months. The FDA is expected to provide a decision on October 25, 2015.
"Our NDA filing for lifitegrast represents an important regulatory milestone, exemplifying Shire's ability to forge new paths in therapeutic areas aligned with our focus in rare and speciality conditions," said Head of Research and Development Philip J Vickers in a statement.
Shares in Shire closed down 1.2% at 5,418.92 pence Thursday.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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