25th Jan 2016 12:12
LONDON (Alliance News) - Shire PLC said Monday that it has resubmitted its new drug application for its dry eye disease treatment lifitegrast to the US Food and Drug Administration.
It has resubmitted the application in response to a letter it received from the FDA in October, requesting an additional study. Shire has included in its resubmission data from its OPUS-3 phase III efficacy and safety trial, with a primary endpoint of patient-reported symptom improvement.
"The NDA for lifitegrast now includes data from five randomized controlled clinical trials, with more than 2,500 patients, making it the largest data set for an investigational stage compound in dry eye disease to date," said Philip Vickers, head of research and development at Shire.
The FDA has 30 days after resubmission to acknowledge its receipt and determine if it is a complete response.
Shares in Shire were up 0.5% at 4,250.00 pence Monday afternoon.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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